Leukemia Clinical Trial
Official title:
A Dose-ranging Phase I/II Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes
necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop
cancer cells from dividing so they stop growing or die. Combining imatinib mesylate and
chemotherapy may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate plus cytarabine in
treating patients who have newly diagnosed chronic myeloid leukemia.
OBJECTIVES:
- Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients
with newly diagnosed chronic phase chronic myeloid leukemia.
- Determine the feasibility of this regimen as defined by dose-limiting toxicity of this
regimen and treatment-related mortality in no more than 5% of these patients.
- Determine the rate and duration of molecular response, complete hematological response,
and complete cytogenetic response in patients treated with this regimen.
- Determine the time to treatment failure of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate and cytarabine.
Patients receive oral imatinib mesylate alone once daily on days 1-21. Patients then receive
oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7. Combination
therapy repeats every 28-42 days for 2 courses. Patients then receive maintenance oral
imatinib mesylate once daily. Treatment continues in the absence of disease progression or
unacceptable toxicity.
Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which at least 5/5, 5/10, or 5/20 patients experience dose-limiting toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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