Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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 cells by blocking the enzymes necessary for their growth. Combining arsenic trioxide with imatinib mesylate may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide when given with imatinib mesylate and to see how well they work in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Imatinib Mesylate

Criteria

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