Status:
COMPLETED
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer ...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolererated dose of arsenic trioxide when administered with imatinib mesylate in patients with accelerated or blastic phase chronic myelogenous leukemia o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of one of the following:
- Chronic myelogenous leukemia (CML) in one of the following phases:
- Blastic phase\*
- Accelerated phase\*
- No appropriate donors for stem cell transplantation NOTE: \*Must have received high-dose (600-800 mg/day) imatinib mesylate of no more than 3 months duration
- Acute lymphoblastic leukemia
- Philadelphia chromosome positive by cytogenetic confirmation
- Patients with only bcr-abl-positive disease by polymerase chain reaction are not eligible
- \> 10% blasts in the bone marrow
- No isolated extramedullary disease
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 2 times ULN
- INR and PTT ≤ 1.5 times ULN (except for patients on anticoagulation therapy)
- Renal
- Creatinine ≤ 2 times ULN
- Cardiovascular
- Baseline QTc intervals \< 480 ms
- No chronic arrhythmias
- No active coronary artery disease
- Other
- No chronic electrolyte abnormalities
- No prior non-compliance to medical regimens
- No patients who are considered potentially unreliable
- No active serious infection
- No other active malignancies except superficial epithelial cancers
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for at least 3 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior peripheral blood stem cell or bone marrow transplantation
- Chemotherapy
- Prior hydroxyurea allowed
- No other concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- More than 4 weeks since prior major surgery and recovered
- Other
- Prior anagrelide allowed
- No concurrent warfarin for therapeutic anticoagulation
- Concurrent low molecular weight heparin is allowed
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00081133
Start Date
December 1 2003
End Date
February 1 2005
Last Update
June 5 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021