Status:
COMPLETED
Cladribine, Cytarabine, and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Lead Sponsor:
University of Rochester
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cladribine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imat...
Detailed Description
OBJECTIVES: * Determine the safety and feasibility of cladribine, cytarabine, and imatinib mesylate in patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia (AML) or blastic phase chronic myelogenous leukemia (CML)
- Refractory AML defined as any of the following:
- Failure to achieve complete response (CR) after 2 courses of induction chemotherapy
- Persistent bone marrow blasts \> 40% after 1 course of induction chemotherapy
- Relapse of disease within 3 months since CR
- Relapsed AML defined as the following:
- Any evidence of disease recurrence after CR (early relapse occurs within 3-12 months and late relapse occurs \> 12 months later)
- No acute promyelocytic leukemia (AML-M3 FAB subgroup)
- PATIENT CHARACTERISTICS:
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin ≤ 2.0 mg/dL
- AST ≤ 2.5 times upper limit of normal
- No known chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
- Renal
- Creatinine \< 2.5 mg/dL (if 2.0-2.5 mg/dL, glomerular filtration rate must be measured and dose of cytarabine adjusted if necessary)
- Cardiovascular
- No New York Heart Association grade III-IV heart disease
- No congestive heart failure
- No myocardial infarction within the past 6 months
- Ejection fraction ≥ 30%
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
- No uncontrolled systemic active infection
- No known HIV infection
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
- No history of other curatively treated malignancy except nonmelanoma skin cancer
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No other concurrent biologic agents
- Chemotherapy
- See Disease Characteristics
- No other concurrent chemotherapy
- Endocrine therapy
- No concurrent birth control pills
- Other
- More than 1 week since any prior investigational agent
- No other concurrent investigational agents or therapies
- No other concurrent anticancer agents
- No concurrent therapeutic anticoagulation with warfarin
- Low molecular weight heparin or heparin allowed for therapeutic anticoagulation
- Mini-dose warfarin (e.g., 1 mg per day) allowed for prophylaxis of central venous catheter thrombosis
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00258271
Start Date
March 1 2005
End Date
October 1 2006
Last Update
October 16 2013
Active Locations (1)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642