Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00336024 : Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
PhasePhase 3
AgesMin: N/A Max: 2 Years
Eligibility
Inclusion Criteria:

- Diagnosis of 1 of the following:

- High-risk medulloblastoma defined by any of the following:

- Residual disease > 1.5 cm²

- Lumbar cerebral spinal fluid cytology positive for tumor cells by analysis
of fluid collected either before definitive surgery or ? 10 days after
definitive surgery unless contraindicated

- M0 disease in children < 8 months of age at diagnosis

- M2 or M3 metastatic disease by MRI

- M4 disease

- Supratentorial primitive neuroectodermal tumor (PNET)(any M-stage)

- Anaplastic medulloblastoma regardless of M-stage or residual tumor

- M0 classic, non-desmoplastic medulloblastoma (R1) with radiographically
measurable residual disease < 1.5 cm^2

- MRI evidence of spinal disease

- Tumor must be negative for INI1 gene

- Has undergone definitive surgery within the past 31 days

- No atypical teratoid rhabdoid tumors

- Biological specimens must be available for correlative laboratory studies

- Life expectancy > 8 weeks

- Creatinine clearance or radioisotope glomerular filtration rate ? 60 mL/min

- Bilirubin ? 1.5 times upper limit of normal (ULN)

- AST and ALT < 2 times ULN

- Shortening fraction ? 27% by echocardiogram

- Ejection fraction ? 47% by radionuclide angiogram

- No evidence of dyspnea at rest

- Pulse oximetry > 94% on room air

- Absolute neutrophil count > 1,000/mm³

- Platelet count > 100,000/mm³ (transfusion independent)

- Hemoglobin > 8 g/dL (RBC transfusions allowed)

- Prior corticosteroids allowed

- No prior radiation therapy or chemotherapy
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00336024      |      Link to official Clinicaltrials.gov listing
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