STI571 in Treating Patients With Recurrent Leukemia
- Registration Number
- NCT00004932
- Lead Sponsor
- Children's Oncology Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 440 mg/m2 imatinib mesylate (ST571) imatinib mesylate - 570 mg/m2 imatinib mesylate (ST571) imatinib mesylate - 260 mg/m2 imatinib mesylate (ST571) imatinib mesylate - 340 mg/m2 imatinib mesylate (ST571) imatinib mesylate -
- Primary Outcome Measures
Name Time Method Survival Length of study To estimate the maximum tolerated dose (MTD) of STI571 administered orally once daily without interruption to children with recurrent Ph+ leukemia.
- Secondary Outcome Measures
Name Time Method Define the anti-leukemic activity of STI571 Length of study To preliminarily define the anti-leukemic activity of STI571 within the confines of a Phase I study.
Characterize the pharmacokinetic behavior Length of study To characterize the pharmacokinetic behavior of STI571 in children with recurrent Ph+ leukemia.
Dose-limiting toxicities Length of study To determine the dose-limiting toxicities (DLT) of STI571 given on this schedule.
Trial Locations
- Locations (234)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center
🇺🇸Long Beach, California, United States
Scroll for more (224 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States