NCT00004932

STI571 in Treating Patients With Recurrent Leukemia

A Phase I Study of STI571 in Ph+ Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia. PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with recurrent Philadelphia chromosome-positive leukemia. * Characterize the pharmacokinetic behavior of this drug in this patient population. * Determine preliminarily the antileukemic activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral imatinib mesylate (STI571) once daily for 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 6 months for 4 years and then annually thereafter. PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study within 3.5 years.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	imatinib mesylate

Timeline

• Start date: 2002-01-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2003-01-27
• Last updated: 2014-02-21

Locations

235 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland