Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I/II Study of Irinotecan and Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
Verified date | October 2017 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 uses high-energy x-rays to kill tumor cells. Irinotecan may make tumor
cells more sensitive to radiation therapy. Giving irinotecan together with whole-brain
radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan when
given together with whole-brain radiation therapy and to see how well they work in treating
patients with brain metastases from solid tumors. (The study of side effects and best dose
has ended as of 4/15/05)
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 120 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of California Davis Cancer Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose and toxicity as assessed by NCI CTC v2.0 (Phase I) (Phase I closed to accrual as of 4/15/05) | |||
Primary | Overall survival (Phase II) | |||
Secondary | Neurocognitive deterioration as assessed by Mini-Mental Status Examination (Phase II) | |||
Secondary | Time to cognitive failure as assessed by Kaplan-Meier (Phase II) |
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