Status:
COMPLETED
Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Solid Tumors
Lead Sponsor:
University of California, Davis
Conditions:
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Eligibility:
All Genders
1-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy us...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of irinotecan hydrochloride administered concurrently with whole-brain radiotherapy in patients with brain metastases from solid tumors. (P...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of brain metastasis from a histologically confirmed solid tumor, meeting the following criteria:
- Must have histologic proof of original malignancy
- No germ cell tumor metastasis
- Biopsy-proven brain metastasis preferred when clinical history and radiographic findings are equivocal
- At least 1 unidimensionally measurable lesion ≥ 50 mm by head contrast CT scan and/or brain MRI
- Patients enrolled in the phase II portion of the study must meet the following Radiation Therapy Oncology Group Recursive Partitioning Analysis staging criteria for brain metastases:
- Class II classification
- Zubrod performance status 0-1 AND any of the following:
- Age \> 65 years
- Extracranial metastasis
- Uncontrolled primary malignancy
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- Life expectancy ≥ 3 months
- Able to participate in the Mini-Mental Status Examination
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Hemoglobin ≥ 9.0 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent medical disease that, in the investigator's opinion, would preclude study participation
- PRIOR CONCURRENT THERAPY:
- More than 21 days since prior chemotherapy
- No prior whole-brain radiotherapy
- No prior DNA topoisomerase I drugs (e.g., irinotecan hydrochloride, topotecan hydrochloride)
- At least 4 days since prior and no concurrent known CYP3A4 inducers, including any of the following:
- Phenytoin
- Carbamazepine
- Phenobarbital
- Hypericum perforatum (St. John's wort)
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00389584
Start Date
December 1 2002
End Date
November 1 2006
Last Update
November 6 2017
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817