Trial summary

Five to ten percent of primary school children fail to learn to read at the standard expected from their intelligence and educational and cultural background. This condition is known as dyslexia.

In 2005-2006, a dyslexia project is being conducted in participating Southern Tasmanian schools.  Past work has shown that some children with normal intelligence have reading problems because of problems with coordinating both eyes to read visual images.  The project aims to screen for vision coordination problems among children with low literacy. It is not currently known what proportion of children who have difficulty reading have vision problems in relation to scanning text with both eyes working together.

The main aim of the Literacy Pathways Project is:

To assess how children may benefit from different programs to assist them with reading. Each program contains a mixture of activities that are based on past work indicating that they have benefited some children with reading problems. The relative importance of the different components within or between the programs is currently not known and is the subject of the educational trial.

Participants are unaware of the intervention status and commercial names of the reading programs in the study. The programs are referred to as the orange, yellow or green program.
Participants are not aware of the content of the other programs. The people conducting the assessments are blind to intervention status.

Analysis - The true group allocation will be removed for the analysis and only added back in at the end. That is, the analyst will only analyse the data being aware of the orange, yellow or green categories but not the intervention status associated with each.

Broad Health ConditionBinocular vision
Literacy
Poor reading due to dyslexia or other conditions but excluding poor reading due to major intellectual disability.

Specific Health ConditionEye
Diseases / disorders of the eye
Mental Health
Learning disabilities

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment19/06/2006

Has the study received ethics approval?Approved

Key inclusion criteria

Children in the lowest decile of literacy according to Grade 3 national literacy and numeracy tests who also have poor stereovision on screening assessment. Children must reside in Southern Tasmania (telephone 0362). 

Minimum age7 Years

Maximum age13 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Major intellectual impairment or epilepsy.

Trial summary

This phase II trial studies how well reduced doses of radiation therapy to the brain and
spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of
brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using
chemotherapy and radiation therapy have been shown to be effective in treating patients with
WNT-driven medulloblastoma. However, there is a concern about the late side effects of
treatment, such as learning difficulties, lower amounts of hormones, or other problems in
performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill
cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine
sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor
cells and may also reduce the late side effects of treatment.

Broad Health Condition

Specific Health ConditionMedulloblastoma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,WA,

Hospital
John Hunter Children's Hospital

Hospital
Women's and Children's Hospital-Adelaide

Hospital
Princess Margaret Hospital for Children

Hospital
Perth Children's Hospital

Phase of TrialPhase 2

Key inclusion criteria

Inclusion Criteria:

    -  Patients must be newly diagnosed and have:

         -  Eligibility confirmed by rapid central pathology and molecular screening review
            on APEC14B1:

              -  Classical histologic type (non LC/A) WNT medulloblastoma

              -  Positive nuclear beta-catenin by immunohistochemistry (IHC)

              -  Positive for CTNNB1 mutation

              -  Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)

    -  Patient must have negative lumbar cerebrospinal fluid (CSF) cytology

         -  Note: CSF cytology for staging should be performed no sooner than 14 days post
            operatively to avoid false positive CSF; ideally, CSF should be obtained between
            day 14 and day 21 to allow for final staging status before enrollment onto the
            study; patients with positive CSF cytology obtained 0 to 14 days after surgery
            should have cytology repeated to determine eligibility and final CSF status;
            patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days
            after surgery do not need cytology repeated; patients with negative CSF cytology
            from lumbar puncture obtained prior to surgery do not need cytology repeated
            post-operatively

    -  Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1;
       patients must have =< 1.5 cm^2 maximal cross-sectional area of residual tumor; whole
       brain magnetic resonance imaging (MRI) with and without gadolinium and spine MRI with
       gadolinium must be performed

    -  Patients must be enrolled, and protocol therapy must be projected to begin, no later
       than 36 days after definitive diagnostic surgery (day 0)

    -  Peripheral absolute neutrophil count (ANC) >= 1000/uL

    -  Platelet count >= 100,000/uL (transfusion independent)

    -  Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)

    -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
       mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

         -  3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and
            females)

         -  6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)

         -  10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)

         -  13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL
            (females)

         -  >= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL
            (females)

              -  The threshold creatinine values were derived from the Schwartz formula for
                 estimating GFR utilizing child length and stature data published by the
                 Centers for Disease Control and Prevention (CDC)

    -  Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and

    -  Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3x ULN);
       for the purpose of this study, the ULN for SGPT is 45 U/L

    -  Central nervous system function defined as:

         -  Patients with seizure disorder may be enrolled if on anticonvulsants and well
            controlled

         -  Patients must not be in status epilepticus, a coma or on assisted ventilation at
            the time of study enrollment

    -  Patients must have receptive and expressive language skills in English, French, or
       Spanish to complete the QoL and neurocognitive assessments; if a patient meets these
       criteria but the parent/guardian speaks a language other than English, French, or
       Spanish, the patient may still be enrolled and tested, and the parent-report measures
       should be omitted

    -  All patients and/or their parents or legal guardians must sign a written informed
       consent; assent, when appropriate, will be obtained according to institutional
       guidelines

    -  All institutional, Food and Drug Administration (FDA), and National Cancer Institute
       (NCI) requirements for human studies must be met

  Exclusion Criteria:

    -  Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar
       CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture
       for assessment of CSF cytology are ineligible

    -  Patients must not have received any prior radiation therapy or chemotherapy
       (tumor-directed therapy) other than surgical intervention and/or corticosteroids

    -  Pregnancy and Breast Feeding

         -  Female patients who are pregnant are ineligible due to risks of fetal and
            teratogenic adverse events as seen in animal/human studies

         -  Lactating females are not eligible unless they have agreed not to breastfeed
            their infants

         -  Female patients of childbearing potential are not eligible unless a negative
            pregnancy test result has been obtained

         -  Sexually active patients of reproductive potential are not eligible unless they
            have agreed to use an effective contraceptive method for the duration of their
            study participation

    -  Patients with a history of moderate to profound intellectual disability (i.e.,
       intelligence quotient [Q)]=< 55) are not eligible for enrollment; PLEASE NOTE:
       Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a
       specific learning disability (e.g., dyslexia) are eligible for this study

Minimum age3 Years

Maximum age21 Years

GenderAll

Can Healthy volunteers participate?No

Trial summary

This research trial studies neuropsychological (learning, remembering or thinking) and
behavioral outcomes in children and adolescents with cancer by collecting information over
time from a series of tests.

Broad Health Condition

Specific Health ConditionChildhood Malignant Neoplasm

Recruitment statusRecruiting

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

Hospital
John Hunter Children's Hospital

Hospital
Sydney Children's Hospital

Hospital
The Children's Hospital at Westmead

Hospital
Royal Children's Hospital-Brisbane

Hospital
Queensland Children's Hospital

Hospital
Women's and Children's Hospital-Adelaide

Hospital
Royal Children's Hospital

Hospital
Princess Margaret Hospital for Children

Hospital
Perth Children's Hospital

Key inclusion criteria

Inclusion Criteria:

    -  The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic
       study that aims to examine neuropsychological, social, emotional, and/or behavioral
       functioning

    -  The patient must have receptive and expressive language skills in English, French, or
       Spanish; if a patient meets these criteria but the parent/guardian speaks a language
       other than English, French, or Spanish, the patient may still be enrolled and tested,
       and the parent-report measures should be omitted

    -  All patients and/or their parents or legal guardians must sign a written informed
       consent

    -  All institutional, Food and Drug Administration (FDA), and National Cancer Institute
       (NCI) requirements for human studies must be met

  Exclusion Criteria:

    -  Patients with a history of moderate to profound intellectual disability (i.e.
       intelligence quotient [IQ] =< 55) are not eligible for enrollment; PLEASE NOTE:
       Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a
       specific learning disability (e.g., dyslexia) are eligible for this study

GenderAll

Can Healthy volunteers participate?No