Leukemia Clinical Trial
Official title:
Phase I Study Of Flavopiridol In Combination With Imatinib Mesylate (STI571, Gleevec) In Bcr/Abl+ Hematological Malignancies
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes
necessary for cancer cell growth. Drugs used in chemotherapy such as flavopiridol use
different ways to stop cancer cells from dividing so they stop growing or die. Combining
imatinib mesylate with flavopiridol may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol and
imatinib mesylate in treating patients with hematologic cancer.
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of flavopiridol and
imatinib mesylate in patients with Bcr/Abl+ hematological malignancies.
- Determine the toxic effects of this regimen in these patients.
- Determine the disease-related effects of this regimen in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
- Correlate response to this regimen with mechanisms of imatinib mesylate resistance in
patients previously treated with imatinib mesylate.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
percentage of blasts in the peripheral blood and bone marrow (less than 15% vs at least 15%)
and recent myelosupressive treatment (no vs yes).
Patients receive oral imatinib mesylate daily and flavopiridol IV over 1 hour on days 2, 9,
and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and flavopiridol 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.
PROJECTED ACCRUAL: A total of 6-80 patients will be accrued for this study within 1 year.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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