Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
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.
OBJECTIVES:

 -  Determine the progression-free survival and response rate of patients with recurrent or
 progressive malignant glioma treated with temozolomide.

 -  Determine whether certain categories of malignant gliomas, such as oligodendroglioma,
 are more sensitive to temozolomide.

 -  Determine the toxicity of this regimen in these patients.

 OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma
 multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent
 anaplastic oligodendroglioma).

 Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every
 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

 PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
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