Status:
UNKNOWN
PHA-739358 in Treating Patients With Chronic Myelogenous Leukemia That Relapsed After Imatinib Mesylate or c-ABL Therapy
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 patien...
Detailed Description
OBJECTIVES: * Explore the clinical efficacy of PHA-739358, in terms of hematological response lasting ≥ 4 weeks, in patients with chronic myelogenous leukemia that relapsed after imatinib mesylate or...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00335868
Start Date
March 1 2007
Last Update
December 18 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781