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Therapeutic Areas: Oncology
Disease Category: Brain Tumor

Trial Information

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor COG ACNS 0332

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

PURPOSE: This randomized phase III trial is studying different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumor.

Inclusion Criteria:

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET)

Newly diagnosed disease

Previously untreated disease

Meets 1 of the following criteria:

• M0 medulloblastoma with > 1.5 cm² residual tumor
• M+ medulloblastoma
• M0 or M+ supratentorial PNET
• Diffusely anaplastic medulloblastoma with any M-stage or residual tumor
• Must have undergone stereotactic biopsy or attempted neurosurgical resection of the tumor within the past 31 days
• The following procedures are required:
  • Pre-operative MRI of the brain with and without contrast
  • Post-operative (preferably within 72 hours after surgery) MRI of the brain with and without contrast**
  • Spinal MRI with and without contrast within 10 days before surgery or 28 days after surgery
  • Lumbar cerebrospinal fluid (CSF) cytological examination obtained pre-operatively or within 31 days after surgery***
• No M4 disease

NOTE: **Not required for patients with M2 or M3 disease or for patients who undergo stereotactic biopsy only
NOTE: ***If a spinal tap is contraindicated, and there is no ventricular CSF available, CSF cytology may be waived for patients with supratentorial tumors OR if there is documentation of spinal subarachnoid metastases (M3); patients with M1 disease must have either an intraoperative-positive CSF by lumbar puncture at the end of surgery OR a positive lumbar CSF obtained more than 7 days after surgery (to rule out surgically-induced false positives

PATIENT CHARACTERISTICS:

• Karnofsky/Lansky performance status 50-100%
• Life expectancy > 8 weeks
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 effective forms of contraception
• Creatinine normal OR creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
• Bilirubin < 1.5 times upper limit of normal (ULN)
• AST and ALT < 2.5 times ULN (5 times ULN for patients on antiseizure medications)
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³ (transfusions not allowed)
• Hemoglobin ≥ 8 g/dL (transfusions allowed)

Exclusion Criteria:

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy or radiotherapy
• No other concurrent experimental therapy
• No concurrent isotretinoin for acne treatment
• No concurrent corticosteroids as an antiemetic during chemotherapy

Patricia Green Sharpe MSN MHSA RN, Director, Department of Clinical Trials/Oncology Data Services
Memorial Health University Medical Center
William & Iffath Hoskins Center for Biomedical Research & Education
4700 Waters Avenue
Savannah, GA 31404
Phone: 912 350-7887
Fax: 912 350-8183
EMail: sharppa1@memorialhealth.com

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