Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma

• Status: Completed
• Trial end date: 2016-01-06
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.

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

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria:

• Bidimensionally measurable disease

• Evaluable disease

• Nonevaluable disease as demonstrated by gross total surgical resection

• No immediate need for cranial irradiation

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Life expectancy ≥ 12 weeks

• Absolute granulocyte count ≥ 1,500/mm³

• Hemoglobin ≥ 10.0 g/dL

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.5 times upper limit of normal (ULN)

• Bilirubin ≤ 2.0 times ULN

• AST ≤ 3.0 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No infection requiring systemic antibiotics within the past 14 days

• No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer

• No unrelated medical problems that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for this malignancy

• No prior radiotherapy to the brain

• No surgery requiring general anesthesia > 2 hours in duration within the past 10 days

• No prior temozolomide

• Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry