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
- 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
- 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
Ronald Paquette, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Stanford University Medical Center||Stanford, California 94305-5408|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Oregon Cancer Institute||Portland, Oregon 97201-3098|