Status:
COMPLETED
Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 eff...
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00087061
Start Date
May 1 2004
End Date
June 1 2005
Last Update
July 18 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095