Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma)
• •* Recurrent or progressive primary CNS neoplasm by contrast-enhanced MRI
• •Tumor progression after prior surgery, radiotherapy, or chemotherapy
• •Measurable or evaluable disease
• •Failed prior standard curative or palliative therapy (phase I only)
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Karnofsky 60-100%
• •Life expectancy
• •At least 3 months
• •Hematopoietic
• •Absolute neutrophil count ≥ 2,000/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hepatic
• •SGPT and SGOT ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
• •Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
• •Bilirubin normal
• •Renal
• •Creatinine ≤ 1.5 times ULN
• •Cardiovascular
• •No myocardial infarction with the past year
• •No heart failure (including cardiac insufficiency controlled by digitalis and diuretics)
• •No irreversible arrhythmias requiring permanent medication
• •No uncontrolled hypertension
• •Gastrointestinal
• •No gastrointestinal dysfunction that would alter absorption or motility, such as any of the following:
• •* Active peptic ulcer
• •* Inflammatory bowel disease
• •* Known intolerance to lactose
• •* Malabsorption syndromes
• •* Intestinal sub-occlusion
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception
• •No active infection
• •No mentally incapacitated patients
• •No other concurrent severe disease that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No concurrent immunotherapy
• •Chemotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• •No more than 1 prior chemotherapy regimen
• •No other concurrent chemotherapy
• •Endocrine therapy
• •Concurrent corticosteroids allowed if dose stable for the past 2 weeks
• •No concurrent hormonal therapy
• •Radiotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy
• •No concurrent radiotherapy
• •Surgery
• •See Disease Characteristics
• •At least 3 weeks since prior surgical resection
• •No prior gastrointestinal surgery that would affect drug absorption
• •Other
• •More than 4 weeks since prior participation in any other investigational drug study
• •More than 72 hours since prior systemic antibiotics
• •No concurrent H2 antagonists, antacids, or proton pump inhibitors
• •* If any of these therapies are necessary, ≥ 3 hours must elapse after gimatecan administration
• •No other concurrent anticancer therapy
• •No other concurrent investigational drugs
• •No other concurrent immunosuppressive agents