Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with interferon alfa in treating patients who have chronic myelogenous leukemia.

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

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Imatinib Mesylate; Interferon-alpha; Interferons

Criteria

DISEASE CHARACTERISTICS:

• Cytogenetically confirmed chronic myelogenous leukemia (CML)

• Less than 15% blasts in peripheral blood or bone marrow

• Less than 30% blasts and promyelocytes in peripheral blood or bone marrow

• Less than 20% basophils in blood or bone marrow

• Platelet count at least 100,000/mm^3

• No leukemia beyond bone marrow, blood, liver, or spleen

• No chloroma

• Phase I (closed to accrual as of 7/9/03):

• Philadelphia (Ph) chromosome-positive CML in chronic phase

• Phase II:

• Newly diagnosed Ph chromosome-positive CML in chronic phase

• Initial diagnosis within 6 months of study

• No prior therapy for CML except hydroxyurea and/or anagrelide hydrochloride

• Phase I (closed to accrual as of 7/9/03) and II:

• No identified sibling donors where allogeneic stem cell transplantation is elected as first-line therapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST or ALT no greater than 2 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No New York Heart Association class III or IV heart disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 methods of effective barrier contraception during and for at least 3 months after study participation

• No other serious uncontrolled medical condition

• No autoimmune disease

• No prior noncompliance to medical regimens or potential unreliability

• No prior grade 3 or greater non-hematologic toxicity due to prior interferon (phase I [closed to accrual as of 7/9/03])

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• No prior bone marrow or peripheral blood stem cell transplantation

• At least 2 weeks since prior interferon alfa (phase I [closed to accrual as of 7/9/03])

Chemotherapy:

• See Disease Characteristics

• At least 6 weeks since prior busulfan (phase I [closed to accrual as of 7/9/03] )

• At least 2 weeks since prior cytarabine (phase I [closed to accrual as of 7/9/03])

• No concurrent chemotherapy

• Concurrent hydroxyurea allowed during the first 3 months of study

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• At least 4 weeks since prior investigational agents other than imatinib mesylate (phase I [closed to accrual as of 7/9/03])

• No concurrent grapefruit juice

• Concurrent anagrelide hydrochloride allowed during the first 3 months of study