Carboplatin and Vincristine Plus Radiation Therapy Followed By Adjuvant Chemotherapy in Treating Young Patients With Newly Diagnosed CNS Embryonal Tumors

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining carboplatin and vincristine with radiation therapy followed by adjuvant chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cisplatin; Cyclophosphamide; Lenograstim; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven high-risk CNS embryonal tumors, including:

• Primitive neuroectodermal tumors

• Atypical teratoid/rhabdoid tumor

• Medulloblastoma

• Desmoplastic medulloblastoma

• Ependymoblastoma

• Medullomyoblastoma

• Spongioblastoma

• Spongioblastoma polare

• Primitive polar spongioblastoma

• Neuroepitheliomatous neoplasms

• Medulloepithelioma

• Neuroblastoma

• Pineoblastoma

• No bone marrow involvement or bone metastases

• No M4 disease

• M3 disease must have evidence of tumor on spinal MRI

PATIENT CHARACTERISTICS:

Age:

• 3 to 21 at diagnosis

Performance status:

• Not specified

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count at least 100,000/mm^3 (transfusion independent)

• Hemoglobin at least 10.0 g/dL (packed red blood cell transfusions allowed)

Hepatic:

• Bilirubin less than 1.5 mg/dL

• SGOT/SGPT less than 2.5 times normal

Renal:

• Creatinine less than 1.5 times upper limit of normal OR

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Prior definitive surgery allowed