PHA-739358 in Treating Patients With Chronic Myelogenous Leukemia That Relapsed After Imatinib Mesylate or c-ABL Therapy

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: PHA-739358 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well PHA-739358 works in treating patients with chronic myelogenous leukemia that relapsed after imatinib mesylate or c-ABL therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of chronic myelogenous leukemia confirmed by bone marrow biopsy

• Chronic, accelerated, or blastic phase disease

• May have T315I mutation in BCR-ABL kinase

• Relapsed after prior imatinib mesylate or c-ABL therapy

• No CNS leukemia

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Blood pressure ≤ 140/90 mm Hg (with or without hypertension treatment for ≥ 1 week)

• Transaminases ≤ 2.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• Creatinine ≤ 1.5 times ULN

• No known history of HIV infection

• No active uncontrolled infection

• No grade 3 or 4 bleeding

• LVEF ≥ 45% by MUGA or ≥ 40% by transthoracic echocardiography

• No medical or psychiatric condition or laboratory abnormalities that would limit study compliance or increase risk during study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 90 (female) or 180 (male) days after completion of study treatment

• No significant cardiovascular disease (i.e., uncontrolled arrhythmias or unstable angina) within the past 6 months

• No major thromboembolic event within the past 6 months, including any of the following:

• Myocardial infarction

• Stroke

• Transient ischemic attack

• Pulmonary embolism

• Noncatheter-related deep-vein thrombosis

PRIOR CONCURRENT THERAPY:

• Recovered from all acute toxic effects (excluding alopecia) of prior therapy

• More than 2 weeks since prior chemoimmunotherapy

• Hydroxyurea must be discontinued 1 day prior to study therapy

• More than 4 weeks since prior major surgery

• No other concurrent approved or investigational anticancer treatment, including chemotherapy, biologic response modifiers, hormones, or immunotherapy

• No other concurrent investigational drugs

• No concurrent participation in another treatment clinical trial