Search results from the Australian New Zealand Clinical Trials Registry

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Broad Health Condition: Cancer
Specific Condition: Head and neck
Recruitment Status: Recruiting

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ACTNSWNTQLDSATASVICWA

Investigating taste changes in patients with head and neck cancer and their association with genes and dietary behaviour

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Trial Information

Trial summary

Project Aims - This project aims to assess the feasibility of conducting a study to determine a patient’s individual taste status prior to receiving cancer treatment, and how these radiotherapy and chemotherapy treatments impact on their taste and dietary behaviour after treatment completion.

Who is it for? - You may be eligible for this study if you are aged 18 years or older and you are undergoing radiotherapy or chemoradiotherapy treatment for head and neck squamous cell cancer.

Study Details - Participants who enrol in this study will be asked to complete a series of questionnaires about their diet and taste perceptions prior to starting treatment, and again at 1 month, 3 months and 6 months after treatment completion. It is anticipated that participants will be able to complete these questionnaires & assessments via a telehealth appointment of approximately 45 minutes, and an additional 30 minutes completing an online survey, at each of the timepoints described.

Study Outcomes - It is hoped this research will provide valuable data on the effect cancer treatments may have on the taste and smell perceptions of patients with head and neck cancer and how this impacts on their ability to eat. This data will also be used to inform a larger study to identify possible genetic markers for these individual variations.

Broad Health ConditionHead and neck cancer
Taste perception
Dietary Intake
Nutritional Status

Specific Health ConditionCancer
Head and neck
Diet and Nutrition
Other diet and nutrition disorders

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Herston

Anticipated date of last participant enrolment10/09/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

All patients aged > 18 years undergoing curative intent definitive radiotherapy or chemoradiotherapy (unilateral or bilateral) for oral cavity, oropharyngeal or hypopharyngeal HNSCC at RBWH who can provide written informed consent. Participants will also need to have appropriate technology (e.g. computer/tablet/smart phone with internet connection) to support telehealth sessions and completion of the online dietary assessments.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Age <18, unable to communicate in English, inability to provide written informed consent, sensory (taste) dysfunction of other medical causes (including history of traumatic brain injury, history of neurological disorders, history of middle ear surgery/infection) and current smoker. 
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Teresa Brown
Primary Sponsor Address: Nutrition & Dietetics Royal Brisbane Women's Hospital Butterfield Street Herston QLD 4029
Primary Sponsor Country: Australia

Trial IDACTRN12621000391875

UTNU1111-1263-5345

Contact person for information and recruitmentDr
Teresa Brown
Department of Nutrition & Dietetics Level 2 James Mayne Building Royal Brisbane & Women's Hospital Butterfield Street Herston QLD 4029
+61 7 3646 6043

Further information iconteresa.brown@health.qld.gov.au
Australia

Magnetic Sentinel Lymph Node Mapping in Oral Squamous Cell Carcinoma: A Phase I Feasibility and Validity Clinical Trial

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Trial Information

Trial summary

The objective of this research program is to investigate new magnetic technology to determine the feasibility of detecting microscopic spread of Oral Squamous Cell Carcinoma (OSCC) to the neck.

Who is it for?
This study will enrol adults aged 18 years or over who have a biopsy proven T1-T2 oral SCC (tongue, RMT, buccal mucosa, FOM, hard palate).

Study details
Study participants will be injected with a single dose of MagTrace or FerroTrace magnetic tracer. One of these two tracers will be delivered around the tumour in 5 injections. The tracer will be used to identify sentinel lymph nodes (nodes that are likely to contain cancer) which will then be surgically removed.

It is hoped this research will provide a new method able to detect cancer metastasis (spread to other body parts), and will also reduce complications associated with oral cancer surgery.  

Broad Health ConditionOral Cancer

Specific Health ConditionCancer
Head and neck

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
SA

Hospital
The Royal Adelaide Hospital - Adelaide

Postcode
5000 - Adelaide

Anticipated date of last participant enrolment31/12/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- Age 18 or older
- Willing to provide informed consent 
- ECOG status 0-2 
- Biopsy proven T1-T2 oral SCC (tongue, RMT, buccal mucosa, FOM, hard palate)
- Clinically and radiologically N0 neck on contrast enhanced CT or gadolinium enhanced MRI +/- (USS or FDG PET) 
- No distant metastases
- Primary tumours amenable to surgical resection 


Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

- Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy 
- Advanced T-stage primary tumour (>T2) 
- Primary tumours not amenable to surgical resection 
- Previous HNSCC
- Previous head and neck radiotherapy at any time
- Lip involvement 
- Allergy or Intolerance to iron oxide or dextran compounds
- Metal implant close to site of sentinel lymph node
- Iron overload disorder 
- Standard contraindications to MRI scanning 
- Pregnant or lactating women  
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Central Adelaide Local Health Network trading as Royal Adelaide Hospital
Primary Sponsor Address: CALHN Research Office RAH Clinical Trial Centre Wayfinder 3D460.02 Level 3, Royal Adelaide Hospital Port Road, Adelaide SA 5000
Primary Sponsor Country: Australia

Trial IDACTRN12620000831987

Contact person for information and recruitmentDr
Giri Krishnen
Royal Adelaide Hospital Port Road, Adelaide SA 5000
+61 8 8222 7158

Further information icongiri.krishnan@adelaide.edu.au
Australia

A Phase 1b, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ST-617 for the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for Head and Neck Cancer

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Trial Information

Trial summary

Introduction
As you are going to be treated with chemoradiation therapy for your head and neck cancer, you will most likely develop oral mucositis. As such this study is testing an experimental treatment for oral mucositis. This experimental treatment is called ST-617. 
Oral mucositis involves painful ulcers or lesions developing in the lining of your mouth.  There are currently no approved medicines to successfully prevent and/or treat oral mucositis for head and neck cancer patients. Most patients are treated with best supportive care (BSC) which includes such things as making sure you are taking care of your mouth properly, providing ice chips or lozenges to suck on, or swishing with a mouthwash.
This study aims to test the safety and tolerability of ST-617 on patients and their oral cavities while they are being treated with chemoradiation for head and neck cancer. There are two arms to this study, Phase 1b and Phase 2. It is hoped that the Phase 1 arm will help determine the recommended dose of ST-617 that will be used in head and neck cancer patients in the Phase 2 study.
ST-617 is a medication that has been widely studied in multiple human clinical trials and belongs to a group of medications that have been shown to help protect cells from damage.
Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with head and neck cancer who is planning to undergo chemoradiation.
Study details
In the Phase 1b part of the study participants will receive either Best Supportive Care (BSC) alone, or BSC plus an oral suspension of ST-617 administered daily for 3 days prior to the start of radiation, and then daily during radiation treatment.
Participants will attend hospital visits for approximately 4 months. After the last visit, their study doctor will check on the status of their cancer every 3 months for up to 1 year after they started radiation.
Most of the exams, tests, and procedures that will be done during this study are part of regular medical care, but will be done multiple times so more information can be gathered. 
Participation in this study will be divided into different visits: Screening Period, Treatment Period, End of Treatment, 30-Day Safety Follow-Up and Response Follow-Up Visits.
Blood will be taken from a vein in the participants’ arm for testing of their general health and to check their medical condition.

Broad Health ConditionOral Mucositis
Head and Neck Cancer

Specific Health ConditionCancer
Head and neck
Oral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,VIC

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Liverpool Hospital - Liverpool

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Barwon Health - McKellar Centre campus - North Geelong

Hospital
The Royal Adelaide Hospital - Adelaide

Postcode
2050 - Camperdown

Postcode
2170 - Liverpool

Postcode
5042 - Bedford Park

Postcode
3215 - North Geelong

Postcode
5000 - Adelaide

Trial location outside Australia

Country
South Africa

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patient Inclusion Criteria
Each patient must meet all the following criteria to participate in the study:

1. Histopathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or nasopharynx.

2. Unknown Human Papillomavirus (HPV) positive primaries thought to be of oropharyngeal origin may be included if other inclusion criteria are met.

3. Documentation of HPV status for tumors of the oropharynx, tonsils or base of tongue. HPV status is determined by testing of the tumor (not an oral swab).

4. Planned therapy to include a continuous course of external beam radiation to include intensity-modulated radiotherapy (IMRT) with concurrent cisplatin monotherapy administered every week (30-40 mg/m2 for 6-7 doses) or every 3-weeks (60-100 mg/m2 for 3 doses).

5. Planned total radiation dose of between 60-72 Gy administered in single daily fractions of 2.0-2.2 Gy.

6. Radiation field must include at least 2 mucosal sites within the oral cavity (buccal mucosa, floor of mouth, lateral or ventral tongue, anterior tonsillar pillars, or soft palate) in which both sites receive a minimum cumulative radiation dose of 55 Gy.

7. Patient able to voluntarily provide written informed consent to participate in the study.

8. Capable of understanding and complying with the protocol requirements.

9. Adult patients aged between 18 to 75 years old.

10. Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.

11. Adequate organ and bone marrow function as defined by:
a. Absolute neutrophil count (ANC) greater than or equal to 1.0 × 10^9/L (1,000/mm^3).
b. Haemoglobin (Hgb) greater than or equal to 9.0 g/dL.
c. Platelets greater than or equal to 75 × 10^9/L (75,000/mm^3).
d. Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN).
e. Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 60 mL/min.
f. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN if no liver involvement, or less than or equal to 5 x ULN with liver involvement.
g. Albumin less than or equal to 3.5 g/dL or within normal range.

12. No evidence of any active oral mucositis (must be Grade 0 on WHO scale).

13. Ability to swish and swallow fluids in mouth without difficulty.

14. Able to minimise time in direct sunlight while on protocol.

15. Sexually active patients must agree to use medically-accepted barrier methods of contraception (e.g., male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study drug.

16. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test at screening. WCBP includes any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal.

17. Patient’s written informed consent to test for the human immunodeficiency virus (HIV).

Minimum age18 Years

Maximum age75 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patient Exclusion Criteria
Patients who meet any of the following criteria will be excluded from the study:

1. Planned continuation of cisplatin or other chemotherapy following radiotherapy.

2. Patients with known infection of Human Immunodeficiency Virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.

3. Known presence in serum of Hepatitis B surface antigen.

4. Evidence of any current active oral mucositis (must be Grade 0 on WHO scale).

5. Prior treatment including:
a. Radiotherapy or brachytherapy to the head and neck;
b. Cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks, or nitrosoureas / mitomycin C within 6 weeks before the first dose of study treatment;
c. Treatment with therapeutic antibody less than 4 weeks before the first dose of study treatment;
d. Small molecule kinase inhibitor or other small molecule investigational agent within 14 days or 5 half-lives of the compound or active metabolites, whichever is greater, before the first dose of study treatment.

6. The patient has not recovered from toxicity due to all prior therapies (i.e., return to pre-therapy baseline or to Grade 0). Persistent > Grade 0 toxicity from prior therapy will be considered by the Sponsor for inclusion if there is no evidence of an overlapping ST-617 toxicity.

7. Major surgery within 21 days prior to first dose of study drug.

8. Current untreated or unresolved oral candidiasis or oral herpes simplex virus (HSV) infection.

9. History of thromboembolic or peripheral vascular disease (including Raynaud’s and systemic lupus erythematosus (SLE)).

10. Grade 2 or greater baseline neuropathy.

11. History of malabsorption or other gastrointestinal disease that may significantly alter the absorption of ST-617 (e.g., greater than or equal to Grade 2 nausea, vomiting or diarrhea).

12. History of poorly controlled Type 1 or Type 2 diabetes mellitus, with a haemoglobin A1c greater than or equal to 8%.

13. Uncontrolled significant intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure within 6 months, hypertension, unstable angina pectoris within 6 months, stroke within 6 months, myocardial infarction within 6 months, or cardiac arrhythmias. (Controlled chronic atrial fibrillation will not be excluded).

14. QTc interval corrected by Fridericia’s method greater than 450 msec for male patients or greater than 470 msec for female patients or history or risk factors for or use of medications known to prolong QTc interval or that may be associated with Torsades de Pointes (TdP) within 7 days of treatment start. CredibleMeds list of drugs known to cause TdP may be used as a reference for this study to determine which drugs are prohibited using the following link: https://crediblemeds.org/new-drug-list or a crediblemeds mobile application.

15. History of other medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the patient’s safety or interfere with the evaluation of the safety of the study agent.

16. Concurrent administration of strong inhibitors of CYP3A4.

17. Concurrent administration of drugs that enhance photosensitivity.

18. The patient has a previously identified allergy or hypersensitivity to components of the study treatment formulation, dithiolethiones or platinum compounds.

19. Pregnant or breast-feeding women.

20. Unable to eat a solid diet due to sequelae of surgery or tumor, or gastrostomy-feeding dependence at baseline.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: PSI CRO Australia Pty. Ltd.
Primary Sponsor Address: Suite 2.01, 16 Giffnock Avenue, Macquarie Park, NSW 2113
Primary Sponsor Country: Australia

Trial IDACTRN12620000541909

Contact person for information and recruitmentMs
Justine Lee
PSI CRO Australia Pty. Ltd. Suite 2.01, 16 Giffnock Avenue, Macquarie Park, New South Wales, 2113.
+61 2 8582 1672

Further information iconjustine.lee@psi-cro.com
Australia

A Phase Ib, single centre, open label study of a therapeutic Human Papillomavirus (HPV) DNA vaccine co-administered with an anti-PD-L1 immunotherapy, Durvalumab (MEDI4376), for recurrent and/or metastatic HPV-related Head and Neck Cancer

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Trial Information

Trial summary

The purpose of this research project is to test whether it is safe to administer a new vaccine (AMV002) in combination with an immunotherapy drug called Durvalumab (MEDI4736) in patients with HPV-related cancer of the tonsil or base of tongue where the cancer has either returned after treatment (recurrent) or spread to other parts of the body (metastases) and now considered incurable. The new vaccine (AMV002) is aimed at promoting the body’s own immune system to develop antibodies that attack cancer cells that have been infected by the human papillomavirus. Durvalumab is an immunotherapy drug, and has been used in the treatment of several other cancer types and aims to overcome the cancer’s ability to dampen down the body’s immune response to the cancer itself.

Who is it for?

You may be eligible to join this study if you are aged 18 and above, have recurrent and/or metastatic HPV-related Head and Neck Cancer

Study details

If you meet all the criteria to take part in the study, you will be assigned to receive the AMV002 and Durvalumab treatment. You will be supplied with a schedule of your required study visits during the treatment and for the follow-up periods of the study.

In particular, on three separate occasions, you will receive two injections (vaccinations) with the vaccine administered at 4 weekly intervals (i.e. 2 injections of 0.5mg AMV002 per patient on days 0, 28 and 56). The vaccination will be carried out by injecting 0.2mL of vaccine into the skin on your forearm(s) using a standard sterile single-use needle and syringe. Durvalumab (MEDI4736) will be administered by IV infusion (1500 mg/patient) on Days 7, 28 and 56.

You will additionally complete a maintenance treatment peiod. This period will involve 13 visits (visits 7 to 19). Durvalumab (MEDI4736) will be administered (1500 mg/patient) every four weeks for 12 months (or until stopping criteria are met).

Safety/tolerability, immunogenicity and efficacy will be assessed at regular intervals during the interventions using clinical examinations and blood tests.

If the study shows that it is safe to administer both drugs at the same time, and blood tests reveal that the vaccine can lead to the production of the antibodies to help fight the cancer, then this combination will be tested in larger human trials to confirm its benefit.

Ultimately this approach may become the standard way in which we treat this type of cancer and may form the basis for the treatment of other cancer types. 

Broad Health ConditionHead and Neck Cancer
HPV

Specific Health ConditionCancer
Head and neck
Infection
Other infectious diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Postcode
4102 - Woolloongabba

Anticipated date of first participant enrolment30/04/2020

Anticipated date of last participant enrolment25/06/2021

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Histologically or cytologically-confirmed recurrent or metastatic or unknown primary of presumed, oropharyngeal squamous cell carcinoma (OPSCC).

Previously received curative or palliative treatment which may include any of the following: surgery, chemotherapy and/or radiotherapy (RT) or presenting with known metastatic disease.

Have results from local testing of HPV positivity for oropharyngeal cancer defined as a positive test for HPV16 DNA or HPV16 mRNA or p16 immunohistochemistry (IHC) testing using CINtec® p16 Histology assay and a 70% cut-off point. If HPV status has previously been tested using one or more of these procedures, no retesting is required, however HPV16 DNA or HPV16 mRNA testing may be performed on archived paraffin-embedded tumour tissue if not previously done.

Confirmation of PD-L1 Status.  (Patients with equal to or greater than 25% of tumour cells with membrane staining of any intensity will be considered PD-L1 positive while those with 0% to 24% of tumour cells with membrane staining will be considered PD-L1 negative).

World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at enrollment.

Able to communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.

Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.

Aged 18 years or older at the time of informed consent.

Males who are not surgically sterile must use a condom from screening through to 90 days after the last dose of Durvalumab, unless they have a female partner who is surgically sterile or post-menopausal. They must refrain from fathering a child during this time.

Women of child-bearing potential (WOCBP) must use highly effective contraceptive measures (failure rate of < 1% per year when used consistently and correctly) and intend to continue use contraception for at least 90 days following completion of treatment. Highly effective contraceptive measures could include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, and sexual abstinence.

Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. 

Participant in otherwise general good health based on medical history and physical examination.

Body weight > 30kg.

Adequate normal organ and marrow function 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck, including patients with Head and Neck Squamous Cell Carcinoma (HNSCC) of unknown primary or non-squamous histologies (e.g., nasopharynx or salivary gland), not specified in the inclusion criteria.

Received any prophylactic or therapeutic vaccine within 28 days, or investigational drug within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study treatment.

Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study.

Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies, other investigational agent) 21 days prior to the first dose of study drug or 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug for patients who have received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C). If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca/MedImmune and the Investigator.

Any previous treatment with a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD1) or programmed death ligand 1 (PD-L1) inhibitor, including Durvalumab.

Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) equal to or greater than 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 2-5 minutes apart).

Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal, inhaled, injected or topical corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) are also an exception to this criterion.

Any unresolved toxicity equal to or great than NCI CTCAE Grade 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.

Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.

Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.

History of allogenic organ transplantation.

Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). 

Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent

History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease for at least 5 years before the first dose of IP and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease

History of leptomeningeal carcinomatosis

Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry

History of autoimmunity or active primary immunodeficiency

Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.

Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of Durvalumab.

Pregnant as confirmed by a positive serum beta human chorionic gonadotropin (ß-HCG) pregnancy test at Screening or subsequent clinic visit.

Inadequate venous access to allow collection of blood samples.

Birthmarks, tattoos, wound or other skin conditions on the forearms that could reasonably obscure injection site reactions.

Received medication known to have anti-HPV activity within 28-days of screening (prior vaccination with HPV prophylactic vaccines is not an exclusion criterion for this study).

Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), known positive Hepatitis B virus surface antigen (HBsAg), Hepatitis C virus (HCV), or Human Immunodeficiency virus (HIV) positive for HIV 1/2 antibodies.

Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Prior randomisation or treatment in a previous Durvalumab clinical study regardless of treatment arm assignment.

Unwilling to abstain from blood donation during the course of the study, and/or has donated blood or plasma within 60 days prior to the Screening visit.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Queensland
Primary Sponsor Address: University of Queensland QLD 4072
Primary Sponsor Country: Australia

Trial IDACTRN12620000406909

UTNU1111-1249-4851

Contact person for information and recruitmentProf
Sandro Porceddu
Director Radiation Oncology Research | Cancer Services Princess Alexandra Hospital | Metro South Health 199 Ipswich Road Woolloongabba QLD 4102
+61 07 3176 7853
+61 07 3176 1983
Further information iconsandro.porceddu@health.qld.gov.au
Australia

Testing whether prochlorperazine can be safely used to move anti-cancer therapy targets temporarily to tumour cell surfaces with combination dose increases of cetuximab anti-EGFR antibody.

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Trial Information

Trial summary

The purpose of this study is to determine if a high dose of an anti-nausea drug (called prochlorperazine) is safe to give to patients during chemotherapy treatment, while also seeing if there is a health outcome benefit to patients.

Who is it for?

You may be eligible for this study if you are an adult who has a confirmed head and neck cancer or triple negative breast cancer or an adenoid cystic cancer of the head and neck region. 

Study details

All patients in this study will receive a high dose of the anti-nausea medication 3 days after the commencement of chemotherapy. After this, all participants will receive the anti-nausea medication weekly, with their chemotherapy. There will be 5 different doses of the chemotherapy given in combination with the anti-nausea medication to participants depending on when the participant joins the study, with the doses increasing over time and only increasing if the doses pass safety reviews. 

It is hoped that this research will help determine if the anti-nausea drug is safe in combination with chemotherapy to treat patients, while also testing whether this has an effect on improving health outcomes.

Broad Health ConditionCancer

Specific Health ConditionCancer
Head and neck
Cancer
Breast

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Postcode
4102 - Woolloongabba

Anticipated date of last participant enrolment1/06/2020

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Radiological and/or histologically confirmed relapsed Head and Neck Squamous Cell Carcinoma/Triple Negative Breast Cancer/Adenoid Cystic Carcinoma of the head and neck region.
	
2.	Predicted life expectancy of greater than three months

3.	Male or female greater than or equal to 18 years of age

4.	ECOG performance status 0-2 

5.	Provide informed consent

6.	Able to commit to 4 hours in the clinic and 24 hours without driving and operating machinery
7.	Female patients of child bearing potential will be required to have a negative pregnancy test prior to entry on the study and be required to practice an effective form of contraception.	
8.	TNBC patients:  histologically confirmed tumour overexpression of EGFR

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.

2.	Known hypersensitivity to EGFR inhibitors.

3.	Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled
cardiac arrhythmia) less than or equal to 1 year before enrolment/randomization.

4.	History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease previous imaging.

5.	Eastern Cooperative Oncology Group (ECOG) performance status greater than 2

6.	On drugs that cause long QTc  


7.	History of prolonged QT interval or prolonged QT interval on baseline ECG

8.	Systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 50 mmHg in two consecutive blood pressure readings within the 1 hour prior to study drug administration.

9.	Previous reaction to antipsychotic medications

10.	Parkinsons disease or other chronic extrapyramidal conditions.

11.	Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.

12.	Subject (male or female) is not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.

13.	High risk for poor compliance.

14.	Any uncontrolled concurrent medical condition that may interfere with the
interpretation of study results.

Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of Queensland
Primary Sponsor Address: Level 7, General Purpose South Building (Building 78) Staff House Road The University of Queensland Brisbane, Queensland 4072
Primary Sponsor Country: Australia

Trial websiteNone

Trial IDACTRN12619001527156

Contact person for information and recruitmentA/Prof
Euan Walpole
Medical Director – Cancer Services Princess Alexandra Hospital and Metro South Health and Hospital Service, Division of Cancer Services, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Qld, 4102. Australia
+61731765564

Further information iconEuan.Walpole@health.qld.gov.au
Australia

Exploratory Phase Ib/IIa Study of Intratumourally Administered Tigilanol Tiglate to Assess Safety, Tolerability and Tumour Response in Patients with Head and Neck Squamous Cell Carcinoma

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Trial Information

Trial summary

This study aims to evaluate the safety, tolerability and signs of efficacy of a new investigational drug called tigilanol tiglate in participants with head and neck cancer. Who is it for?
Patients may be eligible to join this study if aged 18 years or more and have been diagnosed with head and neck squamous cell carcinoma.
Study details:
All participants in this study will receive between one and three tigilanol tiglate injections directly into 1-4 tumours. Tigilanol tiglate may lead to breakdown of tumour blood vessels and recruitment and activation of white blood cells. This leads to rapid tumour cell death. This drug has previously been tested in humans (see QB46C-H01 - ACTRN12614000685617 and QB46C-H02 - ACTRN12614001207606). Participants will be monitored for at least 3 weeks following tigilanol tiglate injection in order to evaluate safety, tolerability, tumour response and pharmacokinetics (the action of the body on the drug).
The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.

Broad Health ConditionHead and neck squamous cell carcinoma.

Specific Health ConditionCancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
4102 - Woolloongabba

Postcode
2010 - Darlinghurst

Trial location outside Australia

Country
India

State
Mumbai, Maharashtra, 400012

Country
India

State
Kolkata, West Bengal, 700160

Anticipated date of first participant enrolment31/10/2019

Anticipated date of last participant enrolment31/12/2021

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

A patient will be eligible for study participation (Stage 1 and Stage 2, if applicable) if they meet all of
the following criteria:
1. An adult (>= 18 years old);
2. Willing and able to provide written informed consent prior to any protocol-required procedures and comply with all local and study requirements;
3. Resectable or unresectable, histologically or cytologically confirmed HNSCC, accessible and amenable for IT injection, that meets at least one of the following:
• refractory to at least one round of conventional therapy; or
• no available standard therapy; or
• patient declined standard therapy after appropriate counselling (with the decision documented); or
• patient awaiting surgery or therapy or is explicitly being monitored with the aim of delaying therapy.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
5. Life expectancy more than 12 weeks;
6. Disease that is measurable (i.e., each target tumour >= 2 mm in diameter that can be accurately measured in at least two dimensions) by calliper. Up to 4 measurable target tumours with a maximum combined volume of 150 cm3 and up to 5 non-target tumours to be selected at the discretion of the PI;
7. Selected target tumours that are suitable for biopsy (multiple 2 mm punch sampling) and patient willingness to provide tumour biopsies;
8. Haemoglobin >= 9.0 g/dL, neutrophils >= 1.5 x 10^9/L, and platelets >= 100 x 10^9/L;
9. Total bilirubin =< 1.5 x upper limit of normal (ULN);
10. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN;
11. Plasma creatinine =< 2.0 x ULN;
12. International Normalised Ratio (INR) and APTT =< 1.5 x ULN;
13. Women of child-bearing potential (i.e., not pre-menarchal, surgically permanently sterile [hysterectomy, bilateral salpingectomy and bilateral oophorectomy], or >= 12 months postmenopausal without an alternative medical cause) must not be pregnant (as demonstrated by negative serum beta-human chorionic gonadotropin [hCG] pregnancy test) and all men must agree to use adequate contraception (i.e., sexual abstinence [only if preferred method of birth control]; oral, intravaginal, or transdermal combined estrogen and progesterone hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progesterone-only hormonal contraception associated with inhibition of ovulation; intrauterine device [IUD]; intrauterine hormone-releasing system [IUS]; bilateral tubal occlusion; or only vasectomized sexual partner[s]) prior to study entry, for the duration of study participation, and for 90 days following the last treatment day. Additionally, men must agree to not donate sperm for the duration of study participation or for 90 days following the last treatment day.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

A patient will be excluded from the study if they meet any of the following criteria:
1. Target tumours intended for treatment immediately adjacent to, or with infiltration into, major arteries or veins;
2. Target tumours intended for treatment located in an area where post-injection swelling could compromise the airway;
3. Target tumours intended for treatment requiring urgent resection;
4. Participated in any investigational intervention study within 30 days prior to study treatment;
5. Treatment with any anti-cancer treatment (e.g., immunotherapy [e.g., anti-PD-1/L1 inhibitor], biological therapy, chemotherapy, anti-cancer vaccine therapy, oncolytic viral or microbial therapy [e.g., T-VEC/Imlygic(TM), toll-like receptor [TLR] agonists, STING or RIG-1], etc.) other than prior tigilanol tiglate injection as part of this study, within 4 weeks prior to study treatment;
6. Oncology related surgery within 4 weeks prior to study treatment;
7. Any previous surgery in the area of the intended target tumour in proximity of the airway (such that tracking of the injected fluid may be unpredictable and could lead to airway swelling);
8. Any radiation therapy to a visceral organ or tumours within 3 weeks prior to study treatment;
9. Any previous radiation of the intended target tumour in proximity of the airway (such that tracking of the injected fluid may be unpredictable and could lead to airway swelling);
10. Unrecovered to CTCAE version 5 Grade 1 or better from the toxic effects of any previous therapy prior to study enrolment, except for fatigue (Grade =< 2) due to radiation treatment and alopecia (Grade =< 2). Other Grade 2 AEs that are deemed as Grade 2 due to replacement hormonal or steroid therapies may qualify for exception to this criterion with approval of the Medical Monitor;
11. Known, uncontrolled CNS metastasis;
12. History of significant tumour bleeding in the target tumour intended for treatment;
13. Therapeutic anticoagulation or antiplatelet agents (e.g., clopidogrel) (Prophylactic doses of low molecular weight heparins or low dose aspirin [=< 150 mg daily] are allowed) (low molecular weight heparin must be stopped at least 24 hours prior to study treatment);
14. A bleeding diathesis or coagulopathy that would make IT injection or biopsy unsafe;
15. Myocardial infarction, unstable angina pectoris, cerebrovascular accident, pulmonary embolism, uncontrolled congestive heart failure, cardiac arrhythmia (except for controlled atrial fibrillation), arterial thrombosis, or transient ischaemic attack within 6 months prior to study treatment;
16. Significant cardiac comorbidity or uncontrolled hypertension (> 150/100 mmHg), despite optimal medical therapy, that may confound the assessment of safety and tolerability;
17. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tigilanol tiglate or other agents used in this study;
18. Uncontrolled bacterial, viral, or fungal infections requiring systemic therapy, known infection with human immunodeficiency virus (HIV), or active infection with Hepatitis B or Hepatitis C;
19. Pregnant or nursing (the effects of tigilanol tiglate on congenital development and nursing infants are unknown);
20. In the opinion of the PI, the patient is an inappropriate candidate for the study;
21. For consideration when entering Stage 2 - Repeat-Dosing only: Any anti-cancer treatment (e.g., immunotherapy, biological therapy, chemotherapy, anti-cancer vaccine therapy, surgery, etc.) to the target tumour since the previous treatment with tigilanol tiglate;
22. For consideration when entering Stage 2 - Repeat-Dosing only: No unacceptable toxicity to a previous tigilanol tiglate injection.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: QBiotics Group Limited
Primary Sponsor Address: 3A/165 Moggill Road, Taringa, QLD, 4068
Primary Sponsor Country: Australia

Trial IDACTRN12619001407189

UTNU1111-1232-3725

Contact person for information and recruitmentMr
Daniel Swart
QBiotics Group Limited, Suite 3A/165 Moggill Road, Taringa, QLD, 4068
+61 738708933

Further information iconenquiries@qbiotics.com
Australia

Intervention study assessing the novel use of seviteronel in androgen receptor positive cancers

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Trial Information

Trial summary

This study's purpose is to facilitate and expedite the clinical testing of SEVI-D in a population with advanced cancer that are androgen receptor (AR)  positive.  

Who is it for?
You may be eligible for this study if you have a solid tumour with clinical/radiological progression on or following last anticancer therapy.  There study has a focus on, but not exclusive to, rare or neglected cancers. 

Study details
All participants will be screened to confirm if their solid tumour is AR positive by the study team.  If eligible, participants will receive the medications of Serivteronel and Dexamethasone (also known as SEVI-D) by oral tablets continuously per cycle (4 weeks). Participants will be asked to have blood tests, scans, complete questionnaire and regularly meet with the study doctor and team.

It is hoped this research will demonstrate this treatment could be beneficial for the treatment of cancers that are known to be human androgen receptor positive.

Broad Health ConditionSolid cancers

Specific Health ConditionCancer
Bladder
Cancer
Bowel - Anal
Cancer
Cervical (cervix)
Cancer
Head and neck
Cancer
Kidney
Cancer
Liver
Cancer
Lung - Non small cell
Cancer
Other cancer types
Cancer
Sarcoma (also see 'Bone') - soft tissue
Cancer
Malignant melanoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment1/08/2018

Anticipated date of last participant enrolment31/07/2020

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy (if standard therapy exists)
2. Clinical or radiological progression on or following last anticancer therapy
3. Patients with AR-positive solid tumours as confirmed by immunohistochemistry
4. Adequate organ system function
5, Ability to comply with study requirements

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Contraindications to investigational product, as listed in the study addendum and outlined in the Investigator Brochure appended to each study module
2. Known history of hypersensitivity to active or inactive components of investigational product
3. Previous treatment with the same agent or same class of agent
4. Treatment with any of the following anticancer therapies prior to the first dose of study treatment:
o Radiation therapy, surgery or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
o Immunotherapy within 28 days prior to the first dose of study treatment;
o Chemotherapy, biologic therapy, or hormonal therapy within 14 days or 5 half lives of a drug prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer)
5. Administration of any investigational treatment within 30 days or 5 half lives
(whichever is longer) prior to receiving the first dose of study treatment;
6. Any additional exclusion criteria specified in the relevant study addendum.
7. Active prostate cancer requiring treatment.
8. Active breast cancer requiring treatment.
9. Symptomatic central nervous system cancer. Subjects with stable neurological function, on stable doses of steroids/antiepileptics over 4 weeks prior to screening are eligible.
10. Corrected QT interval by the Fridericia correction formula (QTcF) on the screening electrocardiogram (ECG) >470 msec. If the screening ECG QTcF interval is >470 msec, it may be repeated once, and if the repeat ECG is <470 msec, the patient may be enrolled.
11. Clinically significant cardiac arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place).
12. Any medical condition that could preclude patient participation in the study, pose an undue medical hazard, or which could interfere with study results.
13. Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system within the previous 6 months.
14. Known active Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C infections.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Address: 370 Victoria Street Darlinghurst NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12618001074280

Contact person for information and recruitmentMr
Robert Kent
The Kinghorn Cancer Centre 370 Victoria St Darlinghurst NSW 2010
+61 2 9355 5711
+61 2 9355 5735
Further information iconSVHS.CancerResearch@svha.org.au
Australia

Phase I non-randomised safety study of prophylactic topical dexamethasone/hyaluronic acid formulation on facial nerves during parotidectomy and neck dissection surgery

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Trial Information

Trial summary

 

This study seeks to determine the safety of applying the potent corticosteroid dexamethasone in a slow release hyaluronic acid gel formulation directly to exposed nerve branches of the facial nerve during standard parotidectomy and neck dissection surgery.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and are undergoing parotidectomy (malignant or benign) or neck dissection surgery.

Study details
Consenting patients will receive the dexamethasone in a slow release gel formulation directly to the exposed nerve during surgery, in which the surgeon will coat exposed branches of the facial nerve with the formulation once. Consenting participants will undergo their standard clinical treatment involving parotidectomy or neck dissection surgery which includes an initial consult involving facial nerve function assessments, parotidectomy or neck dissection surgery and follow-up visits assessing wound healing/infection and facial nerve function over 2 months.

Broad Health ConditionParotid cancer
Neck cancer
Parotidectomy
Neck dissection surgery

Specific Health ConditionCancer
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer
Head and neck

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
The Chris O’Brien Lifehouse - Camperdown

Postcode
2050 - Camperdown

Anticipated date of first participant enrolment31/01/2018

Anticipated date of last participant enrolment31/07/2018

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

•	Undergoing parotidectomy (malignant or benign) or neck dissection surgery
•	Greater than or equal to 18 years of age.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

•	Preoperative assessment that the nerve at risk will need to be intentionally sacrificed
•	Functional assessment by the surgeon indicating that the nerve is not functioning prior to surgery e.g. complete facial palsy
•	Administration of another investigational drug within 30 days prior 
•	Significant neurological or psychiatric disorder
•	Pregnancy  
•	Patients who lack capacity or whom are unable to express informed consent
•	Patients with a mental illness such as to interfere with their ability to understand the requirements of the study or express informed consent
•	Current infective illness 

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: IntraVital Pty Ltd
Primary Sponsor Address: 1/54 Coogee Bay Rd Randwick NSW 2031
Primary Sponsor Country: Australia

Trial IDACTRN12618000077268

Contact person for information and recruitmentDr
Aparna Krishnan
Chris O'Brien Lifehouse 119-143 Missenden Road CAMPERDOWN NSW 2050
+61 02 8514 0131

Further information iconaparna.krishnan@lh.org.au
Australia

A Phase 1 Study to Evaluate the Safety and Tolerability of AB122 in Subjects with Advanced Solid Tumors

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Trial Information

Trial summary

This research study is testing the safety and tolerability of a potential new drug called AB122 in subjects with advanced solid tumours. 

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and have a pathologically confirmed solid cancer that is metastatic, advanced or recurrent with progression for which no alternative or curative therapy exists or standard therapy is not considered appropriate by the subject and treating physician. 

Study details
A major purpose of this study is to find a safe dose range of AB122 that can be given to humans with cancer. To do this, multiple study cohorts will be enrolled and receive ascending doses of AB122. This means that if one dose has passed the safety and tolerability review, the next higher dose will be given to the subsequent patient cohort. The study will stop once the maximum tolerable dose is determined. In addition, the study will look at the amount of study drug in the blood to evaluate the way the body processes the study drug (pharmacokinetics) and the way the study drug affects the growth of tumours in cancer patients (pharmacodynamics).

This research study will help us understand whether AB122, the study drug, can be safely given to patients with cancer.

Broad Health ConditionAdvanced Solid Tumors
Endometrial cancer
Merkel cell carcinoma

Specific Health ConditionCancer
Lung - Non small cell
Cancer
Head and neck
Cancer
Kidney
Cancer
Breast
Cancer
Bowel - Back passage (rectum) or large bowel (colon)
Cancer
Prostate
Cancer
Bladder
Cancer
Ovarian and primary peritoneal
Cancer
Oesophageal (gullet)
Cancer
Malignant melanoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St George Private Hospital - Kogarah

Hospital
Sydney Southwest Private Hospital - Liverpool

Postcode
2217 - Kogarah

Postcode
2170 - Liverpool

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Male or Female adults (18 years or over)

2. Pathologically confirmed non-small-cell lung cancer, squamous cell carcinoma of the head and neck, renal cell carcinoma, breast cancer, colorectal cancer (CRC), prostate cancer, melanoma, bladder cancer, ovarian cancer, endometrial cancer, Merkel cell carcinoma, or gastroesophageal cancer that is metastatic, advanced or recurrent with progression for which no alternative or curative therapy exists or standard therapy is not considered appropriate by the subject and treating physician.

3. ECOG performance status of 0 or 1.

4. Must have at least 1 measurable lesion per RECIST. Subjects with prostate cancer who have bone-only lesions must have progression of 2 lesions or a new lesion and rising prostate-specific antigen levels. The measurable lesion must be outside of a radiation field if the subject received prior radiation.

5. Up to 5 lines of prior systemic therapies for advanced/recurrent and progressing disease (an unlimited number of prior hormonal therapies is allowed).

6. Adequate organ and marrow function.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Prior treatment with an anti-PD-L1, anti-PD-1, anti-CTLA-4, or other immune checkpoint inhibitor or agonist as monotherapy or in combination.

2. Has had prior chemotherapy, targeted small-molecule therapy, or radiation therapy within 2 weeks prior to Day 1 or has not recovered from AEs due to a previously administered agent.

3. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.

4. Use of any vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study therapy.

5. Any active autoimmune disease or a documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.

6. Any acute gastrointestinal symptoms (eg, nausea, vomiting, diarrhea, heartburn) at the time of screening or admission.

7. Underlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous (ie, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms, etc) or obscure the interpretation of toxicity determination or AEs or concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.

8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

9. Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.

10. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Arcus Biosciences, Inc.
Primary Sponsor Address: 3928 Point Eden Way Hayward, CA 94545
Primary Sponsor Country: United States of America

Trial websiteNA

Trial IDACTRN12617001641381

Contact person for information and recruitmentDr
Dominic Lai
Arcus Biosciences, Inc. 3928 Point Eden Way Hayward, CA 94545
+1 212 417 0330

Further information iconClinicalTrialInquiry@arcusbio.com
United States of America

Prospective randomised controlled study of pharyngo-oesophageal dilatation in Head and Neck cancer therapy-induced dysphagia: Evaluation of efficacy and safety

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Trial Information

Trial summary

The primary purpose of this trial is to evaluate the efficacy of pharyngo-oesophageal dilatation for improving ease and comfort of swallowing in patients with head and neck cancer therapy-induced swallowing difficulty.

Who is it for?
You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with head and neck cancer for which surgery and chemoradiation therapy finished at least 12 months previously, which has caused ongoing difficulty swallowing.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either the dilatation procedures, or to receive a single oeosophageal endoscopy during which no dilatation is provided. Participants in the dilatation group will receive a series of dilatation procedures. These involve passage of dilators to expand the calibre of the oesophagus under sedation and will occur at 2-3 weekly intervals. All participants will be followed up for 2 years following the final procedure to evaluate swallowing symptoms and satisfaction with the treatment.

It is hoped that this trial will provide information on whether pharyngo-oesophageal dilatation may be an effective method for reducing symptoms of difficulties swallowing which have been caused by cancer therapies for head and neck cancer patients.

Broad Health Conditiondysphagia
head and neck cancer

Specific Health ConditionOral and Gastrointestinal
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St George Hospital - Kogarah

Postcode
2217 - Kogarah

Anticipated date of last participant enrolment29/12/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1) self-reported problematic pharyngeal dysphagia 12 months beyond the surgeries and chemoradiation for head and neck cancer; 2) abnormal Sydney Swallow Questionnaire score (above 234). 

Minimum age50 Years

Maximum age75 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1) local cancer recurrence; 2) any neurological disorders known to cause pharyngeal dysfunction (e.g. Parkinson's disease, cerebral vascular accident, inflammatory myopathy, motor neuron disease). 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: St George & Sutherland Clinical School, University of New South Wales
Primary Sponsor Address: Clinical Sciences (WRPitney) Building, Short Street, St George Hospital, Kogarah NSW 2217
Primary Sponsor Country: Australia

Trial IDACTRN12617000707369

Contact person for information and recruitmentDr
Peter Wu
Department of Gastroenterology and Hepatology, St George Hospital, Gray St, Kogarah, NSW 2217
+61 2 91132817
+61 2 91133993
Further information iconpeteriungchiang.wu@health.nsw.gov.au
Australia

Phase I Study of Complete Freund’s Adjuvant (CFA) in Patients with Refractory and Relapsed Solid Tumours

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Trial Information

Trial summary

This study will investigate the safety of Complete Freund’s Adjuvant (CFA) in Patients with Refractory and Relapsed Solid Tumours. 

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have a histologically or cytologically confirmed locally advanced or metastatic solid tumor (melanoma, head & neck, sarcoma, renal and other cancers) for which no curable therapy exists.

Study details
This study involves the use of an investigational drug called CFA. "Investigational" means that the drug has not yet been approved by the Therapeutic Goods Administration (TGA) for treatment of cancer. CFA consists of three ingredients: mineral oil, surfactant, and heat-killed mycobacterium. Injection of CFA into tumour creates a localised depot of killed bacteria, which are slowly released over weeks. This causes an influx of immune cells to the site on injection, and initiates a powerful immune response. The other drug (pembrolizumab) is an approved novel agent for the treatment of metastatic melanoma. Participants in the study will receive CFA in combination with pembrolizumab. 

CFA will be administered in 42 day cycles starting at a dose of 0.5 ml for the first cohort of three patients. These patients will be monitored closely and provided there are no safety concerns additional patients will be enrolled and treated with 1.0 ml of CFA and subsequently a third cohort will be enrolled with a starting dose of 2.0 ml of CFA. Once a participant experiences an adverse event as a result of the CFA dose, this dose level will be expanded with three additional patients enrolled. If two of the six participants experience a reaction the dose will be decreased to the previous level and three additional patients will be added. If one of the six patients experience a reaction that dose will be declared the maximum tolerated dose for CFA. Pembrolizumab will be administered following approved guidelines (2mg/kg) on day 2 of the first cycle and then every three weeks. 

Safety of CFA will be assessed at Day 1 of each 42 day cycle. Participants will be followed for up to 30 days after removal from treatment to determine therapeutic benefit and anti-tumour effect of CFA. Patients removed from treatment for unacceptable adverse events will be followed up until resolution or stabilization of the adverse event.

Broad Health ConditionSolid Tumours

Specific Health ConditionCancer
Head and neck
Cancer
Malignant melanoma
Cancer
Sarcoma (also see 'Bone') - soft tissue

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT

Hospital
The Canberra Hospital - Garran

Postcode
2605 - Garran

Anticipated date of last participant enrolment1/11/2017

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Histologically/cytologically confirmed locally advanced or metastatic solid tumors (melanoma, head & neck, sarcoma, renal and other cancers) for which no curable therapy exists. Melanoma patients will be allowed to enroll in the dose escalation phase of single agent study following progression or intolerance of ipilimumab/pembrolizumab (or both). Patients who are not suitable or decline treatment with ipilimumab/pembrolizumab (or both) will also be allowed to participate during dose escalation. Previous treatment with a PD1 inhibitor agent is not allowed in dose expansion phase. However, previous treatment with ipilimumab is allowed in dose expansion phase.

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Adequate marrow function as defined below: 
a-	absolute neutrophil count greater than or equal to 1.0 x 10^9/L
b-	platelets greater than or equal to 100,000 x 10^9/L
c-	INR less than 1.5 x ULN

Evidence of at least one measurable and easily accessible cutaneous or subcutaneous lesion that could be injected with CFA but preferably three lesions (other two for a biopsy and tumour assessment each). In patients who have a single measurable lesion, it can be used for intratumoral injection, biopsy and response measurement.

Adequate liver function as evidenced by bilirubin <1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3 times the ULN or <5.0 x ULN if liver metastases are present.

Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 

Recovery from all AE of prior cancer therapies including surgery and radiotherapy, to baseline or CTCAE Grade greater than or equal to 1, except for alopecia.

No prior therapy with CFA or similar agents. Melanoma, head & neck cancer, sarcoma and renal cancer patients will be allowed to enrol in the dose escalation phase of the study. However, enrolment into dose expansion phase Ib will be restricted to melanoma patients with no prior exposure to anti-PD1 agent.

Patients with treated brain metastases, provided that they are clinically stable for a period of 30 days prior to study entry.

These criteria will also be in effect for the dose escalation and expansion stages of the study

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Preexisting > grade 2 peripheral neuropathy

Treatment with any of the following anti-cancer therapies prior to the first dose of CFA within the stated timeframes: intravenous chemotherapy within a period of 4 weeks (6 weeks for nitrosourea, mitomycin-C), biological therapy (e.g. antibodies) within a period of time that is ~ 5 t1/2 or less than 4 weeks, whichever is shorter, prior to starting study drug, any other investigational agents within a period of time that is < 5 tl/2 or 4 weeks (whichever is shortest) prior to starting study drug, wide field radiotherapy  <4 weeks or limited field radiation for palliation <2 weeks prior to starting study drug.

History of cardiac disease (Congestive heart failure NYHA grade > 2, LVEF < 40% as determined by MUGA scan or ECHO, history of clinically significant ventricular arrhythmias, uncontrolled hypertension, unstable angina pectoris or acute myocardial infarction <6 months prior to starting study drug, QTcF > 450 msec), or history of Torsades de pointes.

Pregnant or nursing (lactating) women.

These criteria will also be in effect for the dose escalation and expansion stages of the study
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Canberra Hospital Medical Oncology Department
Primary Sponsor Address: Medical Oncology Clinical Trials Building 19, Level 5 Canberra Hospital Yamba Drive Garran, ACT, 2605
Primary Sponsor Country: Australia

Trial IDACTRN12616001637437

Contact person for information and recruitmentMrs
Olive Doig
Building 19, Level 5 Canberra Hospital Yamba Drive Garran, ACT, 2605
+612 6244 3856

Further information iconOlive.Doig@act.gov.au
Australia

An evaluation of the role of Magnetic resonance Imaging (MRI) in Mucosal Primary Head and Neck Cancer

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Trial Information

Trial summary

This study will evaluate the role of magnetic resonance imaging (MRI) in the treatment of Mucosal Primary Head and Neck Cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with histologically-proven invasive primary squamous cell carcinoma of mucosal primary head and neck region or suspect tumours for mucosal primary head and neck cancer. Study details: Imaging studies are not routinely performed during radiotherapy for head and neck cancer. In this study, all participants will receive multiple additional MRI sequences before, during and after radiotherapy treatment (with or without chemotherapy). MRI sequences used include DWI, R2*, and DCE. The results from all scans will be evaluated with respect to tumour response, local control, disease free survival and overall survival. The main purpose of this study is to see whether new MRI techniques during and after radiotherapy treatment provides the doctors with accurate information which predicts the later response of mucosal primary head and neck cancer to the treatment and also evaluates tumour recurrence following treatment.

Broad Health ConditionHead and Neck Cancer

Specific Health ConditionCancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Liverpool Hospital - Liverpool

Hospital
Campbelltown Hospital - Campbelltown

Postcode
2170 - Liverpool

Postcode
2560 - Campbelltown

Anticipated date of first participant enrolment27/04/2016

Anticipated date of last participant enrolment31/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- 18 years or older
- Have the ability to give informed consent
- Histologically-proven invasive primary squamous cell carcinoma of mucosal primary head and neck region or patients with tumours strongly suspicious for mucosal primary head and neck cancer due to clinical features AND fine needle aspiration (FNA) cytology assessment
- Primary mucosal head and neck cancer (greater than or equal to T2 and/or greater than or equal to N1) AND no evidence of metastatic disease on staging PET/CT or CT (chest +/- abdomen +/- pelvis) 
- Patient undergoing curative intent primary radiotherapy +/- chemotherapy

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

- Contraindication to MRI studies including significant claustrophobia, pacemaker/implantable defibrillator, implanted metals eg. Intraocular clips, and/or known allergic reaction to Gadolinium (Gd)-DTPA
- Previous radiotherapy and/or surgery in the head and neck region 
- Other malignancy (history of malignancy within 5 years)
- Pregnant
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Myo Min
Primary Sponsor Address: Liverpool Cancer Therapy Centre 1 Elizabeth St, Liverpool NSW 2170
Primary Sponsor Country: Australia

Trial IDACTRN12616000534482

UTNU1111-1181-6110

Contact person for information and recruitmentDr
Yuvnik Trada
Liverpool Cancer Therapy Centre, Locked Bag 7103 Liverpool BC 1871 NSW
+61 (02) 8738 9806
+61 (02) 8738 5299
Further information iconyuvnik.trada@health.nsw.gov.au
Australia

The PACT Study: Psychosocial Assessment, Care and Treatment of patients with urological and head and neck cancers.

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Trial Information

Trial summary

This study is developing, and evaluating the feasibility, cost and acceptability of, a patient-centred, integrated model of psychosocial care for people receiving treatment for urological or head and neck cancers. 
Who is it for? 
You will be eligible to join this study if you are aged 18 years or above and have been diagnosed with a urological cancer or a head and neck cancer, for which you are receiving inpatient and/or outpatient care at John Hunter Hospital. 
Trial details 
All participants in this study will receive treatment, as required, under the PACT (Psychosocial Assessment, Care and Treatment) model. As part of this newly developed model of care, all inpatient and outpatient urology and head and neck cancer patients will be screened at their first diagnostic or treatment visit and at each subsequent follow-up visit, using the Distress Thermometer (DT) and accompanying Problem Checklist. This will be used to develop a care plan to address any issues identified through the screening and second-line inquiry. The care plan will facilitate the provision of care which is tailored to the specific needs of patients, and promote continuity of care across care settings and providers; including with health care providers (HCPs) in rural and regional areas. 
Participants will be asked to report experiences of their cancer care at baseline, and at 21 and 30 months after intervention commencement. It is anticipated that implementation of this model will improve continuity of care, increase health care professionals' awareness, confidence, knowledge and skills to discuss and respond to patients' specific concerns, and improve access to specialised psychological care services.

Broad Health ConditionUrological cancers
Head and Neck cancers

Specific Health ConditionCancer
Head and neck
Cancer
Prostate
Cancer
Other cancer types

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
John Hunter Hospital Royal Newcastle Centre - New Lambton

Postcode
2305 - New Lambton

Anticipated date of first participant enrolment14/03/2013

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Key patient inclusion criteria are: a) aged 18 years or over, b) diagnosed with a urological cancer or a head and neck (H&N) cancer, and c) receiving inpatient and/or outpatient care at John Hunter Hospital. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Key patient exclusion criteria are: a) aged below 18 years, b) not diagnosed with a urological or a head and neck (H&N) cancer, and c) not receiving any inpatient or outpatient care at John Hunter Hospital. 
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Address: High St UNSW KENSINGTON NSW 2052
Primary Sponsor Country: Australia

Trial IDACTRN12613000916741

Contact person for information and recruitmentMs
Hayley Candler
c/- CTNMH, University of Newcastle, PO Box 833, NEWCASTLE NSW 2300
+61240335118
+61240335692
Further information iconhayley.candler@unsw.edu.au
Australia

A clinical trial of adoptive T-cell immunotherapy for patients with Epstein-Barr virus-associated nasopharyngeal carcinoma.

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Trial Information

Trial summary

This study is evaluating the effect of using T cell immunotherapy following standard chemotherapy for the treatment of nasopharyngeal cancer (NPC).

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic nasopharyngeal cancer and your clinician is planning to treat you with standard chemotherapy.

Trial details
All participants in this study will receive standard chemotherapy with gemcitabine and cisplatin according to their clinician’s standard clinical care. Following this, they will undergo the experimental immunotherapy. This involves infusing Epstein-Barr Virus (EBV) specific T-cells intravenously (i.e. directly into the vein) up to 6 times, at fortnightly intervals. 

Participants will be regularly assessed for up to 38 weeks in order to evaluate their response to treatment, and the safety and tolerability of treatment.

Broad Health ConditionMetastatic nasopharyngeal carcinoma

Specific Health ConditionCancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Princess Alexandra Hospital - Woolloongabba

Trial location outside Australia

Country
Hong Kong

Anticipated date of first participant enrolment18/08/2015

Anticipated date of last participant enrolment2/12/2019

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Age 18 years or above
2 . Histologically proven NPC (non-keratinising or undifferentiated carcinoma) at first diagnosis
3. Provision of Informed consent.   Approved hospital interpreters will be used for patients who do not have sufficient understanding of English for informed consent to be obtained without the use of an interpreter.
4. First  relapse of NPC; either metastatic disease or loco-regionally recurrence that is not resectable 
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
6. Life expectancy of at least 6 months, as determined by the clinical investigator
7. Adequate haematological and biochemical function 
8. Completion of a medical questionnaire
9. Suitable to commence treatment, or currently receiving treatment , for metastatic disease or recurrent loco-regional disease not amenable to surgery

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. EBV negative tumour
2 . Serological evidence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis infection (N.B. Positive serology for HBV indicating previous but cleared infection with HBV is not an exclusion criterion) 
3. Significant non-malignant disease (e.g. severe cardiac or respiratory dysfunction)
4.. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial
5. Inability to provide informed consent, including patients with severe cognitive impairment, intellectual disability or mental illness
6. Prior cancers, except those diagnosed greater than 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5 percent, or successfully treated nonmelanoma skin cancer, or carcinoma in situ of the cervix.
7. Currently receiving immunosuppressive therapy, including corticosteroids. At the discretion of the clinical investigator the patient can receive anti-emetics
8. Pregnant, lactating, or unwilling to use adequate contraception
Contact details and further information

Sponsor Primary Sponsor Type: Charities/Societies/Foundations
Primary Sponsor Name: QIMR Berghofer Medical Research Institute
Primary Sponsor Address: 300 Herston Road, Herston, Brisbane, QLD, 4006
Primary Sponsor Country: Australia

Trial websiteNil

Trial IDACTRN12613000866707

Contact person for information and recruitmentDr
Michelle Neller or Katherine Matthews
QIMR Berghofer Medical Research Institute 300 Herston Road Herston, QLD 4006
+61-7-3362 0412
+61 7 3845 3510
Further information iconimmunotherapy@qimrberghofer.edu.au
Australia

Eating As Treatment (EAT): A stepped wedge, randomised control trial of a health behaviour change intervention provided by dietitians to improve nutrition in head and neck cancer patients undergoing radiotherapy

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Trial Information

Trial summary

This study is evaluating the effectiveness of a dietitian delivered health behaviour intervention to reduce malnutrition in head and neck cancer patients undergoing radiotherapy.

Who is it for? 

This study is taking place within six Australian Hospitals. You may be eligible to join this study if you are aged 18 years or more, and have a confirmed diagnosis of cancer involving the nasopharynx, oropharynx, oral cavity, larynx, or hypopharynx requiring definitive or postoperative radiotherapy with curative intent. 

Trial details 

All sites will begin in the ‘control’ condition – dietitians will provide ‘treatment as usual’. Participants recruited during this phase will receive treatment as usual by trained dietitians according to standard hospital practice. At a randomly determined time point, researchers will attend the hospitals to provide training to the dietitians. Dietitians will then provide ‘EAT’ (Eating as Treatment) as part of standard dietetic consultations (weekly during treatment, fortnightly for six weeks and then ‘as needed’). You will not be aware of whether you are participating in the 'control' or 'intervention' phase.

EAT is a dietitian delivered health behaviour change intervention designed to improve health behaviours of head and neck cancer patients and maintain their nutrition over the course of their radiotherapy. Of particular interest are behaviours related to sufficient daily nutritional intake, either orally or via feeding tube. 

Participants will be regularly assessed for up to 12 weeks post radiotherapy treatment in order to evaluate nutrition status. Information about mood, smoking and alcohol use, therapeutic alliance and radiotherapy side effects will also be collected from participants. Medical records will be reviewed to collect a range of information including total radiotherapy treatment time, unplanned hospital visits, length of stay, dietitian contact and referral to appropriate services for depression. 

Broad Health ConditionHead and Neck Cancer Patients Undergoing Radiotherapy
Depression

Specific Health ConditionCancer
Head and neck
Diet and Nutrition
Other diet and nutrition disorders
Mental Health
Depression

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD,SA,WA,VIC

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Peter MacCallum Cancer Institute - East Melbourne

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Mater Adult Hospital - South Brisbane

Hospital
Toowoomba Hospital - Toowoomba

Hospital
St Andrew's Toowoomba Hospital - Toowoomba

Postcode
4350 - Toowoomba

Postcode
4350 - Rockville

Postcode
6009 - Nedlands

Postcode
3002 - East Melbourne

Postcode
5000 - Adelaide

Postcode
4101 - South Brisbane

Postcode
4102 - Woolloongabba

Anticipated date of first participant enrolment8/04/2013

Anticipated date of last participant enrolment27/03/2015

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Pathologically confirmed diagnosis of cancer involving the Nasopharynx, Oropharynx, Oral Cavity, Larynx, or Hypopharynx requiring definitive or postoperative radiotherapy with curative intent

Regional nodal irradiation included in PTV1 (as a minimum ipsilateral levels II-III)

Receiving a prescribed dose of at least 60 Gy

Definitive or post operative adjuvant Radiotherapy intent permitted

Radiotherapy as sole modality or Chemoradiation (including neoadjuvant and adjuvant chemotherapy) permitted

Participation of patients on other clinical trial protocols permitted provided these trials are likely to continue throughout the period of this study. This will ensure that patients in both the control and intervention group are exposed to similar radiotherapy treatments.

> 18 years of age

Available for follow-up for at least 6 months

Life expectancy greater than 6 months

Written informed consent

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patient not meeting the eligibility criteria

Patient cannot communicate in English

Patient with organic brain diseases impairing ability to complete questionnaires satisfactorily

Patients where significant oral or pharyngeal mucositis is not expected as a complication of radiotherapy treatment (patients with T1 / T2 glottic carcinoma undergoing small field radiotherapy or T1/T2 tonsil cancer undergoing unilateral treatment are not eligible)
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Newcastle
Primary Sponsor Address: Professor Amanda Baker, School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, 2308
Primary Sponsor Country: Australia

Trial IDACTRN12613000320752

UTNU1111-1137-6830

Contact person for information and recruitmentDr
Alison Beck
Trial Coordinator, Priority Research Centre for Translational Neuroscience and Mental Health, University of Newcastle, PO Box 833, Newcastle, NSW 2300
+61 2 4033 5039
+61 2 4033 5692
Further information iconAlison.Beck@newcastle.edu.au
Australia

TROG 12.01 A Randomised Trial of Weekly Cetuximab and Radiation versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma

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Trial Information

Trial summary

This study aims to compare radiation treatment combined with either cetuximab or cisplatin in patients with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC) (located at the base of tongue or tonsil)

Who is it for?
You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC). You should not have received any prior treatment for this cancer.

Trial details;
Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive radiation treatment 5 days a week over 7 weeks, in conjunction with weekly doses of a drug called cetuximab. This drug is administered intravenously, i.e. directly into the vein. 

Participants in the other group will receive radiation treatment 5 days a week over 7 weeks in combination with the chemotherapy drug cisplatin, which is also administered intravenously.

Participants will be assessed weekly during treatment, then at 1, 3, 5, 9, 13 weeks post-treatment and at months 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, 48, 54, and 60 post-completion of treatment. Assessments will involve blood tests, questionnaires, clinical examination, hearing tests, swallowing tests, and radiological examination. The main research question being answered is whether those treated with weekly cetuximab and conventionally fractionated radiotherapy will experience less acute symptom severity than patients receiving weekly cisplatin and conventionally fractionated radiotherapy.

Broad Health ConditionHPV positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Specific Health ConditionCancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,QLD,SA,WA,VIC

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Calvary Mater Newcastle - Waratah

Hospital
Peter MacCallum Cancer Institute - East Melbourne

Hospital
The Canberra Hospital - Garran

Hospital
Liverpool Hospital - Liverpool

Hospital
Riverina Cancer Care Centre - Wagga Wagga

Hospital
The Chris O’Brien Lifehouse - Camperdown

Hospital
Westmead Hospital - Westmead

Hospital
The Townsville Hospital - Douglas

Hospital
St George Hospital - Kogarah

Hospital
Flinders Medical Centre - Bedford Park

Hospital
Austin Health - Austin Hospital - Heidelberg

Hospital
Sir Charles Gairdner Hospital - Nedlands

Hospital
Gold Coast Hospital - Southport

Trial location outside Australia

Country
New Zealand

State
Auckland

Country
New Zealand

State
Palmerston North

Anticipated date of first participant enrolment1/05/2013

Anticipated date of last participant enrolment1/06/2018

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Aged 18 years or older
2. Has provided written Informed Consent for participation in this trial 
3. Histologically confirmed squamous cell carcinoma of the oropharynx with p16 positive status confirmed locally by immunohistochemistry 
4. Stage III (excluding T1-2N1) or stage IV (excluding T4, N3, and distant metastasis) if smoking history of < /=10 pack years. If > 10 pack years nodal disease must be N0 – N2a. 
5. If an excisional biopsy has been performed, patients remain eligible for the study provided there is clinically measurable disease prior to commencing RT. The residual disease should still meet the stage criteria required for the trial e.g. excisional biopsy of a node with residual T3 primary, or tonsillectomy for T1 primary with residual > N2a nodes.
6. No prior treatment for oropharyngeal cancer
7. Adequate haematological, renal, and hepatic function as defined by, 
a)  Absolute neutrophil count (ANC, segs + bands) > /= 1.5 x 109/L
b) Platelet count > /= 100 x 109/L
c) Total bilirubin < /= 1.5 x upper normal limit 
d) ALT  < /= 2.5 x upper normal limit 
e) Calculated creatinine clearance (Cockcroft-Gault formula) or isotopic GFR > 55ml/min 
8. ECOG performance status score of 0-1 
9. Participants capable of childbearing are using adequate contraception and intend to continue use of contraception for at least 6 months following completion of treatment
10. Negative pregnancy test within 72 hours prior to randomisation of women who are of childbearing potential
11. Suitable for follow-up for at least 24 months as per trial protocol.
12. Sufficient proficiency in English, cognitive capacity and willingness to complete questionnaires

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. History of unknown primary of the head and neck
2. T4, N3 or distant metastases
3. Smoking history >10 pack years with N2b or c nodal status
4. Women who are pregnant or lactating.
5. Previous radiotherapy to the area to be treated (excluding superficial radiotherapy for a cutaneous malignancy)
6. Previous cisplatin or carboplatin chemotherapy
7. Prior EGFR targeted therapy of any kind
8. Primary surgery to the affected area (excisional biopsy allowed)
9. Peripheral neuropathy > /= grade 2 (CTCAE v4.0)
10. Sensori-neural hearing impairment >= grade 2 (CTCAE v4.0, hearing impaired, not enrolled on a monitoring program) which may be exacerbated by cisplatin (Audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion) 
11. Tinnitus > /= grade 2 (CTCAE v4.0)
12. History of interstitial lung disease or evidence of interstitial lung disease on pre-registration CT
13. History of myocardial infarction within 12 months prior to study entry, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled psychotic disorders, active serious infections, active peptic ulcer disease, immunosuppression due to post-organ transplantation or use of immunosuppressants for autoimmune disorders
14. Patients known to be HIV positive
15. Other cancer that was diagnosed:
a) more than 5 years prior to current diagnosis with (i) subsequent evidence of disease recurrence or (ii) clinical expectation of recurrence is greater than 10% or
b) within 5 years of the current diagnosis, with the exception of successfully treated basal cell or squamous cell skin carcinoma, in situ melanoma, or carcinoma in situ of the cervix
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Trans-Tasman Radiation Oncology Group
Primary Sponsor Address: TROG Central Office PO Box 88 Waratah NSW 2298
Primary Sponsor Country: Australia

Trial websitewww.trog.com.au

Trial IDACTRN12613000279729

Contact person for information and recruitmentMs
Anetta Matera
Peter MacCallum Cancer Centre Locked Bag No 1, A’Beckett St, Melbourne, VIC 8006, Australia.
+61 3 9656 3661

Further information iconAnetta.Matera@petermac.org
Australia

Phase I pilot of a Mindfulness-Based Stress Reduction intervention for Head and Neck Cancer patients receiving treatment of curative intent.

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Trial Information

Trial summary

This research project is a Phase I pilot study which aims to develop and manualise a version of Mindfulness-Based Stress Reduction (MBSR) suitable for individual administration to Head and Neck Cancer (HNC) patients during the active stage of cancer treatment of curative intent. Members of our research team have previously demonstrated that HNC patients receiving treatment of curative intent reach a threshold of clinically significant distress both immediately prior to and during treatment, and also experience a decline in health-related quality of life (HRQoL) in the weeks following treatment. These findings are consistent with previous research which has shown that patients experience high levels of distress following the chronic functional impairment and disfigurement that is a common outcome of treatment for HNCs, and points to the need for effective psychological interventions to assist coping during and following treatment for HNCs. MBSR, as demonstrated by another of our team members, has shown success in reducing psychological distress associated with other forms of cancer, including breast and prostate cancer. As no reported studies exist that use MBSR with HNC patients, we intend to evaluate whether MBSR may be suitable for use in this population. We also aim to establish whether participants’ levels of psychological distress, HRQoL, mindfulness attention and awareness, intrusive cognitions, self-compassion and shame can be effectively measured in this setting. We plan to examine the feasibility (assessed through the feasibility of and compliance and fidelity to the intervention) and acceptability of MBSR therapy to participants through examining the accrual and attrition rates for this pilot study, and further explore participant’s experiences, both positive and negative, of MBSR through a post-intervention semi-structured interview. Finally, we aim to see whether MBSR delivered by a suitably qualified and experienced mental health professional is applicable and feasible for use in a hospital context.

Broad Health ConditionHead and Neck Cancer
Psychosocial distress

Specific Health ConditionCancer
Head and neck
Mental Health
Depression
Mental Health
Anxiety

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Peter MacCallum Cancer Institute - East Melbourne

Postcode
3002 - East Melbourne

Anticipated date of first participant enrolment16/01/2013

Anticipated date of last participant enrolment3/01/2014

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Eligibility for participation in this study is a diagnosis for the first time of a potentially curable cancer in the head and neck region (excluding cancers exclusively involving skin), where the patient has agreed to undertake cancer treatment with curative intent the recruiting site, Peter MacCallum Cancer Centre East Melbourne. Eligibility of patients to participate will be evaluated by oncologists and/or the nurse co-coordinator. Participants must also be aged 18 years or older at the time of recruitment to be considered for inclusion in this study.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

A patient will not be eligible for this study if they are being actively treated for another cancer; or another severely debilitating illness, cannot speak or understand English adequately, or have been diagnosed with an intellectual disability, dementia or active psychotic illness. Participants who have been recruited into other time-intensive studies at the recruiting site, Peter MacCallum Cancer Centre, will not be approached to participate in this study.
Contact details and further information

Sponsor Primary Sponsor Type: Charities/Societies/Foundations
Primary Sponsor Name: Beyond Blue Limited (beyondblue)
Primary Sponsor Address: PO Box 6100 Hawthorn West VIC 3122
Primary Sponsor Country: Australia

Trial IDACTRN12613000271707

Contact person for information and recruitmentDr
Jeremy Couper
Locked Bag 1 A'Beckett Street Victoria 8006
+61 3 96561828
+61 3 96561095
Further information iconjeremy.couper@petermac.org
Australia

Early tube feeding in head and neck cancer

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Trial Information

Trial summary

This study aims to compare the outcome of early tube feeding compared to commencement of feeding as per current standard practice in patients undergoing gastrostomy prior to treatment for head and neck cancer. 

Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with head and neck cancer, and have been referred for a preventive gastrostomy (insertion of feeding tube into the stomach) prior to treatment for your cancer. 

Trial details Participants in this trial will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will commence two supplementary feeds per day at the time of feeding tube insertion (gastrostomy). These feeds will be in addition to the patient's usual dietary intake and will continue throughout cancer treatment. Participants in the other group will receive standard care. This involves water flushes via the gastrostomy throughout cancer treatment and feeds will be commenced by the dietitian as clinically indicated during treatment. 

Participants will be assessed at baseline and 3 months post completion of treatment in order to determine impact on nutrition outcomes, quality of life and clinical outcomes.

Broad Health ConditionHead and neck cancer
Malnutrition

Specific Health ConditionCancer
Head and neck
Diet and Nutrition
Other diet and nutrition disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Royal Brisbane Hospital

Anticipated date of first participant enrolment1/07/2012

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Diagnosed with head and neck cancer
AND
Referred for prophylactic gastrostomy prior to treatment

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

patients with severe malnutrition at diagnosis
OR
patients with moderate malnutrition and severe dysphagia at diagnosis (requiring puree/liquid diets)
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Teresa Brown
Primary Sponsor Address: Dept Nutrition and Dietetics, RBWH Level 2 James Mayne Building Butterfield Street Herston QLD 4029
Primary Sponsor Country: Australia

Trial IDACTRN12612000579897

UTNU1111-1131-0924

Contact person for information and recruitmentMs
Teresa Brown
Dept Nutrition and Dietetics Level 2 James Mayne Building, RBWH Butterfield Street Herston QLD 4029
+617 3646 7997
+617 3646 1874
Further information iconteresa_brown@health.qld.gov.au
Australia

Surgery without radiotherapy as treatment for low risk cutaneous head and neck squamous cell carcinoma

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Trial Information

Trial summary

This study aims to determine the efficacy of surgery without radiotherapy as treatment for low risk cutaneous head and neck squamous cell carcinoma. 

Who is it for? 
You may be eligible to join this study if you are aged 18 years or more and have low-risk cutaneous head and neck squamous cell carcinoma for which you have previously received no treatment. 

Trial details
All participants in this trial will undergo surgical treatment without additional radiotherapy. Surgical treatment includes removal of all relevant lymph nodes of the neck.


You will be assessed for a period of up to 5 years to determine disease specific survival, the incidence of recurrence and associated consequences [assessment will be done by regular clinical examinations plus/minus ultrasound].

Broad Health ConditionCutaneous head and neck squamous cell carcinoma

Specific Health ConditionCancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Anticipated date of first participant enrolment1/01/2012

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

previously untreated cutaneous head and neck squamous cell 
carcinoma

Pathology stage 1 of N1S3 (single node less than or equal to 3cm)

Treated with curative intent

Appropriate neck dissection based on location of the nodal metastasis and primary tumour plus/minus lymphoscintigraphy

Pre-operative PET scan is encouraged to ensure no nodal disease outside planned surgical dissection field  (this will be left to the discretion of the treating clinician)

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Prior to inclusion in the study the clinician must ensure the tumour is low-risk.  This should include a review of the pathology and discussion with colleagues within a multidisciplinary team meeting.

Exclusion criteria include adverse clinicopathological features according to the ITEM prognostic score
Immunosuppression
Extracapsular nodal spread (or if the lesion is a soft tissue deposit)
Involved margins
or close margins with an infiltrating pattern of spread (cf encapsulated/pushing)

Also indications for radiotherapy for the primary tumour
Perineural or lymphovascular invasion

Additional exclusion criteria
Surgeon concern regarding tumour contamination of the operative field
Patient is unable or unwilling to attend follow up reliably
Clinical (Physical, radiological or pathological) evidence of distant metastases
Significant cognitive or psychiatric disorder (unable to understand informed consent)
Coexisting malignancy
Pregnancy/lactation
Contact details and further information

Sponsor Primary Sponsor Type: Charities/Societies/Foundations
Primary Sponsor Name: Sydney Head and Neck Cancer Institute
Primary Sponsor Address: The Chris O'Brien Lifehouse at RPA, Missenden Road, Camperdown, NSW, 2050
Primary Sponsor Country: Australia

Trial IDACTRN12611001159943

Contact person for information and recruitmentA/Prof
A/Prof. Jonathan Clark
Level 5, Gloucester House, Royal prince Alfred Hospital Missenden Road, Camperdown, NSW, 2050
61295154019
61295153179
Further information iconjcjc@tpg.com.au
Australia

The effect of Taxotere, Cisplatin and 5-Fluorouracil (TPF) induction chemotherapy on intratumoral hypoxia in advanced head and neck squamous cell cancer

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Trial Information

Trial summary

This study looks at the impact of TPF chemotherapy (combined Taxotere, Cisplatin and 5-Fluorouracil) on squamous cell (skin) cancer of the head and neck as measured by the oxygen levels in the tumour. 

Who is it for? 
You can join this study if you have locally advanced or locally recurring squamous cell carcinoma of the oral cavity or laryngeal region, which has not been previously treated. 

Trial details 
Participants will all receive treatment with TPF (combined Taxotere, Cisplatin and 5-Fluorouracil) chemotherapy followed by chemoradiation which is the standard treatment for locally advanced or locally recurrent head and neck cancer. The study aims to test whether chemotherapy with TPF gets rid of low oxygen levels in tumours as detected by FAZA PET imaging uptake (a way to measure oxygen levels in the tumour) prior to chemoradiation. FAZA uptake is measured prior to treatment and again after 3 cycles of TPF. The response rate to chemotherapy will also be assessed with a CT scan before and after chemotherapy and the response to chemoradiation will be determined by a FDG PET scan at the completion of treatment. The response to treatment will be correlated with the level of hypoxia in the tumour.

Broad Health Conditionadvanced head and neck squamous cell cancer

Specific Health ConditionCancer
Head and neck

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment1/01/2010

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- Aged 18 years or older
- previously untreated squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
- Histologically or cytologically confirmed squamous cell carcinoma
- stage 3 or 4 disease
- adequate hematological, renal, hepatic and pulmonary function
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) criteria
- creatinine clearance > or = 60ml/min

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

- women who are pregnant or lactating
- previous radiotherapy to area to be treated
- prior diagnosis of cancer
- clinical evidence of metastatic disease
- pre existing motor or sensory neurotoxicity or neuropathy > or = grade 1
- clinically significant sensorineural hearing loss
- active uncontrolled infection
- unstable cardiac disease requirin treatment
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Peter MacCallum Cancer Centre
Primary Sponsor Address: St Andrews Place East Melbourne, Vic 3002
Primary Sponsor Country: Australia

Trial IDACTRN12609000642280

Contact person for information and recruitment
poppy Kypreos
Centre for Biostatistics & Clinical Trials Peter MacCallum Cancer Centre Level 2, 10 St Andrews Place East Melbourne Vic 3002
+61 3 9656 1268
+61 3 9656 1420
Further information iconpoppy.kypreos@petermac.org
Australia