A Phase I Study of STI571 in Ph+ Leukemia
A Phase I Study of STI571 in Ph+ Leukemia
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.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Recurrent Philadelphia (Ph) chromosome-positive leukemia
Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR
Chronic myelogenous leukemia with resistance to interferon alfa with any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Birmingham, Alabama 35233, United States
San Diego, California 92120, United States
San Francisco, California 94115, United States
Lexington, Kentucky 40536-0284, United States
Baltimore, Maryland 21201-1595, United States
Baltimore, Maryland 21231-2410, United States
Worcester, Massachusetts 01655, United States
Albuquerque, New Mexico 87131, United States
Brooklyn, New York 11203, United States
Stony Brook, New York 11790-7775, United States
Winston-Salem, North Carolina 27157-1081, United States
Lackland Air Force Base, Texas 78236-5300, United States
St. John's, Newfoundland and Labrador A1B 3V6, Canada
San Juan, 00936-5067, Puerto Rico