Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.


Study summary:

OBJECTIVES: Primary - Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs. - Determine whether this drug has sufficient activity to warrant further development in these patients. (phase II) Secondary - Determine the qualitative and quantitative toxic effects of this drug in these patients. - Determine the pharmacokinetic behaviors of this drug in these patients. - Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients. - Determine the antitumor activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are stratified according to the concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no). - Phase I: Patients receive oral gimatecan once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gimatecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive gimatecan as in phase I at the MTD. Patients are followed for at least 1 month and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 30-83 patients (30-42 for phase I [15-21 per stratum] and 21-41 for phase II) will be accrued for this study within 24 months.


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


NCT ID:

NCT00087061


Primary Contact:

Principal Investigator
Timothy F. Cloughesy, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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