Brain and Central Nervous System Tumors
Conditions
Keywords
recurrent adult brain tumor, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma
Brief 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.
Detailed description
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.
Interventions
DRUGtemozolomide
Sponsors
Herbert Irving Comprehensive Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed