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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00602667




Registration number
NCT00602667
Ethics application status
Date submitted
10/01/2008
Date registered
28/01/2008
Date last updated
27/11/2024

Titles & IDs
Public title
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
Scientific title
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
Secondary ID [1] 0 0
R01CA154619
Secondary ID [2] 0 0
SJYC07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Induction Chemotherapy
Treatment: Drugs - Low-Risk Therapy
Treatment: Drugs - High-Risk Therapy
Treatment: Drugs - Intermediate-Risk Therapy

Experimental: Low-Risk Patients - Patients with GTR/M0 medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.

Note: Accrual to the low-risk medulloblastoma cohort is closed as of 12/2/2015. Accrual to the low-risk high grade glioma remains open.

Experimental: High-Risk Patients - Patients with CNS metastatic disease will receive induction chemotherapy and high-risk therapy.

Experimental: Intermediate-Risk Therapy - Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.


Treatment: Drugs: Induction Chemotherapy
All patients will receive 4 identical cycles of induction chemotherapy including highdose (5 g/m2 or 2.5g/m2 for patients less than or equal to 31 days of age at enrollment) intravenous methotrexate and standard dose vincristine, cisplatin, and cyclophosphamide.

Treatment: Drugs: Low-Risk Therapy
Induction will be followed by further conventional chemotherapy with carboplatin, cyclophosphamide, and etoposide. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).

Treatment: Drugs: High-Risk Therapy
High risk patients will also receive vinblastine with each course of induction chemotherapy. Induction will be followed by either chemotherapy with targeted intravenous topotecan and cyclophosphamide or optional craniospinal irradiation (CSI). CSI will be offered only to patients who reach 3 years of age by the end of induction only. After consolidation, all patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).

Treatment: Drugs: Intermediate-Risk Therapy
Induction will be followed by consolidation focal radiotherapy (RT) to the tumor bed. Patients less than 12 months old upon completion of induction will receive low risk chemotherapy to delay RT until the age of 12 months. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).

Note: The option to receive focal proton beam irradiation was suspended 10/29/2015. Focal photon beam irradiation continues as part of the treatment plan.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients
Timepoint [1] 0 0
From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment
Primary outcome [2] 0 0
Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup
Timepoint [2] 0 0
From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment
Primary outcome [3] 0 0
Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients
Timepoint [3] 0 0
From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after
Secondary outcome [1] 0 0
Number of Participants With Chromosomal Abnormalities
Timepoint [1] 0 0
Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
Secondary outcome [2] 0 0
Numbers of Patients With Gene Alterations
Timepoint [2] 0 0
Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
Secondary outcome [3] 0 0
Numbers of Patients With Molecular Abnormalities by Tumor Type
Timepoint [3] 0 0
Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
Secondary outcome [4] 0 0
Number of Successful Collections for Frozen and Fixed Tumor Samples
Timepoint [4] 0 0
Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment
Secondary outcome [5] 0 0
Event-free Survival (EFS) Compared to Historical Controls
Timepoint [5] 0 0
From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years
Secondary outcome [6] 0 0
Overall Survival (OS) Compared to Historical Controls
Timepoint [6] 0 0
1 year after treatment initiation of last patient
Secondary outcome [7] 0 0
Percentage of Patients With Objective Responses Rate to Induction Chemotherapy
Timepoint [7] 0 0
From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)
Secondary outcome [8] 0 0
Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
Timepoint [8] 0 0
From on-study date up to 4 months after on-study date
Secondary outcome [9] 0 0
Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
Timepoint [9] 0 0
At completion of consolidation therapy (up to 6 months after on-study date)
Secondary outcome [10] 0 0
Percent of Patients With Sustained Objective Responses Rate After Consolidation
Timepoint [10] 0 0
8 weeks after completion of consolidation therapy (up to 8 months after on-study date)
Secondary outcome [11] 0 0
Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received
Timepoint [11] 0 0
From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)
Secondary outcome [12] 0 0
Percent of PET Scans With Loss of Signal Intensity
Timepoint [12] 0 0
Up to 3 times during RT consolidation
Secondary outcome [13] 0 0
Concentration of Cerebrospinal Fluid Neurotransmitters
Timepoint [13] 0 0
Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date
Secondary outcome [14] 0 0
Number and Type of Genetic Polymorphisms
Timepoint [14] 0 0
At study enrollment (Day 0)
Secondary outcome [15] 0 0
Pharmacogenetic Variation on Central Nervous System Transmitters
Timepoint [15] 0 0
At study enrollment (Day 0)
Secondary outcome [16] 0 0
Number of Participants With Endocrinopathy
Timepoint [16] 0 0
Baseline, end of therapy, and at 6- and 24-months after completion of therapy
Secondary outcome [17] 0 0
Longitudinal Change in Growth Hormone Secretion
Timepoint [17] 0 0
Baseline, end of therapy, and at 6- and 24-months after completion of therapy
Secondary outcome [18] 0 0
Methotrexate Clearance in Induction Cycle 1
Timepoint [18] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)
Secondary outcome [19] 0 0
Methotrexate Clearance in Induction Cycle 2
Timepoint [19] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [20] 0 0
Methotrexate Clearance in Induction Cycle 3
Timepoint [20] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [21] 0 0
Methotrexate Clearance in Induction Cycle 4
Timepoint [21] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [22] 0 0
Methotrexate Volume of Central Compartment in Induction Cycle 1
Timepoint [22] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [23] 0 0
Methotrexate Volume of Central Compartment in Induction Cycle 2
Timepoint [23] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [24] 0 0
Methotrexate Volume of Central Compartment in Induction Cycle 3
Timepoint [24] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [25] 0 0
Methotrexate AUC0-66h in Induction Cycle 1
Timepoint [25] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [26] 0 0
Methotrexate AUC0-66h in Induction Cycle 2
Timepoint [26] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [27] 0 0
Methotrexate Volume of Central Compartment in Induction Cycle 4
Timepoint [27] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [28] 0 0
Methotrexate AUC0-66h in Induction Cycle 3
Timepoint [28] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [29] 0 0
Methotrexate AUC0-66h in Induction Cycle 4
Timepoint [29] 0 0
Pre-infusion and 6, 23, 42, 66 hours from start of MTX
Secondary outcome [30] 0 0
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1
Timepoint [30] 0 0
42 hours from start of MTX
Secondary outcome [31] 0 0
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2
Timepoint [31] 0 0
42 hours from start of MTX
Secondary outcome [32] 0 0
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3
Timepoint [32] 0 0
42 hours from start of MTX
Secondary outcome [33] 0 0
Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4
Timepoint [33] 0 0
42 hours from start of MTX
Secondary outcome [34] 0 0
Cyclophosphamide Clearance in Induction Chemotherapy
Timepoint [34] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [35] 0 0
Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1
Timepoint [35] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [36] 0 0
Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2
Timepoint [36] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [37] 0 0
Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1
Timepoint [37] 0 0
Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose
Secondary outcome [38] 0 0
Cyclophosphamide AUC0-24h in Induction Chemotherapy
Timepoint [38] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [39] 0 0
Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
Timepoint [39] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [40] 0 0
4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
Timepoint [40] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [41] 0 0
Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
Timepoint [41] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [42] 0 0
Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
Timepoint [42] 0 0
Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
Secondary outcome [43] 0 0
4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy
Timepoint [43] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [44] 0 0
4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
Timepoint [44] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [45] 0 0
4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
Timepoint [45] 0 0
Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
Secondary outcome [46] 0 0
CEPM AUC0-24h in Induction Chemotherapy
Timepoint [46] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [47] 0 0
CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1
Timepoint [47] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [48] 0 0
CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2
Timepoint [48] 0 0
Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion
Secondary outcome [49] 0 0
CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1
Timepoint [49] 0 0
Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose
Secondary outcome [50] 0 0
Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan
Timepoint [50] 0 0
Pre-infusion, 5 min., 1, and 3 hours from end of infusion
Secondary outcome [51] 0 0
Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan
Timepoint [51] 0 0
Pre-infusion, 5 min., 1, and 3 hours from end of infusion
Secondary outcome [52] 0 0
Topotecan Clearance in Consolidation Chemotherapy
Timepoint [52] 0 0
Pre-infusion, 5 min., 1, and 3 hours from end of infusion
Secondary outcome [53] 0 0
Topotecan Apparent Oral Clearance in Maintenance Chemotherapy
Timepoint [53] 0 0
Pre-dose, 0.25, 1.5 and 6 hours post-dose
Secondary outcome [54] 0 0
Topotecan AUC0-24h in Consolidation Chemotherapy
Timepoint [54] 0 0
Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion
Secondary outcome [55] 0 0
Topotecan AUC0-24h in Maintenance Chemotherapy
Timepoint [55] 0 0
Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose
Secondary outcome [56] 0 0
Erlotinib Apparent Oral Clearance
Timepoint [56] 0 0
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
Secondary outcome [57] 0 0
Erlotinib Apparent Volume of Central Compartment
Timepoint [57] 0 0
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
Secondary outcome [58] 0 0
Erlotinib AUC0-24h
Timepoint [58] 0 0
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
Secondary outcome [59] 0 0
OSI-420 AUC0-24h
Timepoint [59] 0 0
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
Secondary outcome [60] 0 0
Rate of Local Disease Progression
Timepoint [60] 0 0
1 year after completion of radiation therapy for last patient
Secondary outcome [61] 0 0
Rate of Distant Disease Progression
Timepoint [61] 0 0
1 year after completion of radiation therapy for last patient
Secondary outcome [62] 0 0
Neurocognitive Performance Related to Global Cognitive Functioning as Measured by Cognitive Composite Scores and Estimated IQ Scores
Timepoint [62] 0 0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Secondary outcome [63] 0 0
Neurocognitive Performance Related to Attention as Measured by Attention Problems T-scores
Timepoint [63] 0 0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Secondary outcome [64] 0 0
Neurocognitive Performance Related to Processing Speed as Measured by Visual Matching Standard Scores
Timepoint [64] 0 0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Secondary outcome [65] 0 0
Neurocognitive Performance Related to Executive Functioning as Measured by Global Executive Composite T-scores
Timepoint [65] 0 0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Secondary outcome [66] 0 0
Neurocognitive Performance Related to Working Memory as Measured by Working Memory T-scores
Timepoint [66] 0 0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Secondary outcome [67] 0 0
Neurocognitive Performance Related to Verbal Fluency as Measured by Retrieval Fluency Standard Scores
Timepoint [67] 0 0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Secondary outcome [68] 0 0
Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Motor Integration (VMI) T-scores
Timepoint [68] 0 0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Secondary outcome [69] 0 0
Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Perception T-scores
Timepoint [69] 0 0
Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy
Secondary outcome [70] 0 0
Change in Neurostructure, Especially White Matter Volume and Integrity
Timepoint [70] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [71] 0 0
Change in Neurostructure, Especially White Matter Volume and Integrity
Timepoint [71] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [72] 0 0
Change in Neurostructure, Especially White Matter Volume and Integrity
Timepoint [72] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [73] 0 0
Change in Neurostructure, Especially White Matter Volume and Integrity
Timepoint [73] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [74] 0 0
Change in Neurostructure, Especially White Matter Volume and Integrity
Timepoint [74] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [75] 0 0
Change in Neurostructure, Especially White Matter Volume and Integrity
Timepoint [75] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [76] 0 0
Change in Neurostructure, Especially White Matter Volume and Integrity
Timepoint [76] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [77] 0 0
Change in Neurostructure, Especially White Matter Volume and Integrity
Timepoint [77] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [78] 0 0
Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe
Timepoint [78] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
Secondary outcome [79] 0 0
Change in Quantitative MR Measures in the Right Frontal-parietal Regions
Timepoint [79] 0 0
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)

Eligibility
Key inclusion criteria
Histologically confirmed newly diagnosed CNS tumors of any of the following :

* Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic medulloblastoma)
* Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma)
* Pineoblastoma
* Atypical teratoid rhabdoid tumor (ATRT)
* Choroid plexus carcinoma
* High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features, high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal tumor, glioblastoma multiforme), or gliosarcoma,
* Ependymoma (including all ependymoma histological variants)
* Age < 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma patients = 3 and < 5years old at diagnosis who have non-metastatic disease with no more than 1cm2 of residual tumor are also eligible.

* Meets criteria for 1 of the following risk groups:
* Low-risk group:

* Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity

* Focal areas of anaplasia or other atypical features suggesting more aggressive phenotype in a tumor otherwise considered nodular desmoplastic should be treated on the intermediate-risk group, with final risk stratification at the discretion of principal investigator and study pathologist
* No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF)

* Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease when lumbar puncture is medically contraindicated
* Intermediate-risk group assignment when there is no other evidence of metastasis and CSF sampling is not possible
* Gross total resection, defined as residual tumor or imaging abnormality (not definitive for residual tumor) with a size of < 1 cm2 confirmed on postoperative CT scan or MRI
* Brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size < 1 cm2) and otherwise meets criteria for the low-risk group, the patient will be classified as low-risk
* Desmoplastic medulloblastoma patients who are =3 -<5 years of age will NOT be eligible for the low risk arm of the protocol.
* Intermediate-risk group:

* Histologically confirmed nodular desmoplastic medulloblastoma with less than gross total resection and no evidence of metastasis
* Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no evidence of CNS metastasis
* Medulloblastoma patients who are =3 and < 5 yrs of age irrespective of histology and with no evidence of CNS metastasis
* High-risk group:

* Any eligible histologic diagnosis with evidence of CNS metastasis
* Patients with extraneural metastasis are eligible for treatment on the high-risk group

PATIENT CHARACTERISTICS:

* Lansky performance status = 30 (except for posterior fossa syndrome)
* WBC > 2,000/mm3
* Platelets > 50,000/mm3 (without support)
* Hemoglobin > 8 g/dL (with or without support)
* ANC > 500/mm3
* Serum creatinine < 3 times upper limit of normal (ULN)
* ALT < 5 times ULN
* Total bilirubin < 3 times ULN

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No more than 31 days since prior definitive surgery
* No prior radiotherapy or chemotherapy other than corticosteroid therapy
Minimum age
No limit
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
Accrual to date
Final
293
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Lady Cilento Children's Hospital, Brisbane - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
St. Jude Children's Research Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Florida
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Cancer Institute (NCI)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Pew Charitable Trusts
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amar Gajjar, MD
Address 0 0
St. Jude Children's Research Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00602667