Leukemia Clinical Trial
Official title:
A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining
chemotherapy and STI571 may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571
in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.
OBJECTIVES:
- Determine the maximum tolerated dose of daunorubicin when combined with imatinib
mesylate, vincristine, and prednisone in patients with lymphoid blastic phase chronic
myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the frequency of hematologic and cytogenetic responses in patients treated
with this regimen.
- Determine the duration of response of this patient population treated with this
regimen.
- Determine the survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of daunorubicin.
Patients who have not previously received imatinib mesylate receive oral imatinib mesylate
on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days
receive oral imatinib mesylate on days 22-35. All patients receive daunorubicin IV over 2-3
minutes on days 1-3, vincristine IV over 1 minute on days 1, 8, 15, and 22, and oral
prednisone on days 1-28. Patients with more than 5% residual blasts in bone marrow on day 28
receive a second course in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of daunorubicin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are treated at the recommended phase II dose.
PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study.
;
Primary Purpose: Treatment
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