Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant glioma

• Glioblastoma

• Gliosarcoma

• High-grade glioma

• Anaplastic astrocytoma

• Anaplastic mixed oligoastrocytoma

• Anaplastic oligodendroglioma

• Anaplastic ependymoma

• Must have completed radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• SGOT/SGPT less than 3 times ULN

• Alkaline phosphatase less than 2 times ULN

Renal:

• BUN less than 1.5 times ULN

• Creatinine less than 1.5 times ULN

Pulmonary:

• Pulmonary function test with diffusion greater than 50 OR

• Clearance by the pulmonary service

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No AIDS-related illness

• No nonmalignant systemic disease that would preclude study

• No acute infection requiring IV antibiotics

• No psychiatric condition that would preclude study compliance

• No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)

• No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 2 weeks since prior radiotherapy

Surgery:

• Not specified