NCT00015860

STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	daunorubicin hydrochloride
DRUG	imatinib mesylate
DRUG	prednisone
DRUG	vincristine sulfate

Timeline

• Start date: 2001-05-01
• Completion: 2003-10-01
• First posted: 2003-01-27
• Last updated: 2013-06-24

Locations

5 sites across 1 country: United States