Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

• Status: Unknown status
• Trial end date: 1969-12-31
• 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.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.

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

Details

• Lead Sponsor: Herbert Irving Comprehensive Cancer Center
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven recurrent or progressive malignant glioma of one of the following types:

• Anaplastic oligodendroglioma or oligoastrocytoma

• Anaplastic astrocytoma

• Glioblastoma multiforme (stratum closed to accrual 11/30/01)

• Patients who have failed radiotherapy are eligible

• Measurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

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

• Platelet count greater than 100,000/mm^3

• Hemoglobin greater than 10 g/dL

Hepatic:

• SGOT or SGPT less than 3 times upper limit of normal (ULN)

• Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)

Renal:

• BUN less than 1.5 times ULN

• Creatinine less than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• No other serious concurrent infection or other medical illness that would preclude study entry

• No frequent vomiting or partial bowel obstruction

• HIV negative

• No AIDS-related illness

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent epoetin alfa

Chemotherapy:

• At least 6 weeks since other prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)

Surgery:

• Recovered from prior surgery

Other:

• No other concurrent investigational agents

• Concurrent anticonvulsant therapy allowed