Leukemia Clinical Trial
Official title:
A Phase I Trial of Imatinib Mesylate (Gleevec, Formerly Known as STI571) in Combination With Daunorubicin and Cytarabine for C-kit Positive Relapsed AML
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the
enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and
cytarabine, work in different ways to stop the growth of cancer cells, either by killing the
cells or by stopping them from dividing. Giving imatinib mesylate together with daunorubicin
and cytarabine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate
when given together with daunorubicin and cytarabine in treating patients with relapsed
acute myeloid leukemia.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) and recommended phase II dose of imatinib
mesylate in combination with daunorubicin hydrochloride and cytarabine in patients with
relapsed acute myeloid leukemia.
Secondary
- Assess the non-dose-limiting toxicities associated with this regimen in these patients.
- Determine any preliminary evidence of clinical activity of this regimen in these
patients.
OUTLINE: This is an open-label, dose-escalation study of imatinib mesylate.
Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7.
Patients also receive oral imatinib mesylate once daily beginning on day 1 and continuing
until disease progression or unacceptable toxicity. Patients with persistent leukemia on day
14 bone marrow biopsy but ≥ 50% reduction in bone marrow blasts receive 5 more days of
cytarabine and 2 more days of daunorubicin while continuing imatinib mesylate.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1
of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated
at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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