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

 -  Determine progression-free survival of patients with newly diagnosed anaplastic
 oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.

 -  Determine the response rate in these patients.

 -  Assess the quality of life of patients with AO or MOA treated with this regimen.

 OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to
 disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).

 Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every
 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

 Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for
 the first year after completion of treatment, every 4 months for the second year, every 6
 months for the third and fourth years, and once a year thereafter.

 After completion of study treatment, patients are followed periodically.

 PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
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