Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

• Status: Active, not recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cisplatin; Cyclophosphamide; Etoposide; Etoposide phosphate; Lenograstim; Leucovorin; Levoleucovorin; Methotrexate; Thiotepa; Vincristine

Criteria

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