Cladribine, Cytarabine, and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Blastic Phase Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cladribine and cytarabine together with imatinib mesylate may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with cladribine and cytarabine in treating patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Cladribine; Cytarabine; Imatinib Mesylate

Criteria

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