Phase I Study Of The Combination Of 17-AAG And Imatinib Mesylate (Gleevec) In Patients With Blastic Phase, Accelerated Phase Of Chronic Mesylate Leukemia (CML) Or Patients With Chronic Phase CML Who Have Not Achieved A Cytogenetic Response With Imatinib Mesylate
- Determine the maximum tolerated dose and dose-limiting toxicity of
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with imatinib
mesylate in patients with chronic myelogenous leukemia.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study of
Patients receive oral imatinib mesylate on days 1-21 and 17-AAG IV over 1 hour on days 1, 4,
8, and 12. Courses repeat every 21 days in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of 17-AAG 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. Once the MTD is determined, an additional cohort
of 6-10 patients receives treatment at the recommended phase II dose.
PROJECTED ACCRUAL: Approximately 21-42 patients will be accrued for this study within 1.5
Masking: Open Label, Primary Purpose: Treatment
Charles A. Schiffer, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|