Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
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 with
 anaplastic oligodendroglioma.
OBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed,
 progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this
 drug in this patient population.

 OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed
 anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive
 oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients with
 progressive or recurrent disease (at baseline) continue treatment in the absence of disease
 progression or unacceptable toxicity. Patients with newly diagnosed disease continue
 treatment for a maximum of 4 courses before radiotherapy in the absence of disease
 progression or unacceptable toxicity. Patients with responding disease may receive an
 additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study
 treatment.) Patients are followed every 8 weeks for 2 years.

 PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic
 oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy Newly
 diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At least
 1.5 cm2 by MRI

 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
 expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet
 count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5
 times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline phosphatase
 less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN
 Other: Neurologically stable No nonmalignant systemic disease No acute infection treated
 with intravenous antibiotics No frequent vomiting No medical condition (e.g., partial bowel
 obstruction) that would interfere with oral medication intake No other prior or concurrent
 malignancy except surgically cured carcinoma in situ of the cervix or basal cell or
 squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or
 nursing Negative pregnancy test Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No
 concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy:
 No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine
 therapy: Must be on stable dose of steroids for at least 1 week prior to study Concurrent
 steroids allowed Radiotherapy: See Disease Characteristics No concurrent radiotherapy
 Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be
 enrolled within 28 days of surgery or biopsy) Recovered from prior major surgery Other: No
 other concurrent investigational drugs