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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00045422

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining interferon alfa with imatinib mesylate may kill more cancer cells.

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

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: recombinant interferon alfa Drug: imatinib mesylate	Phase 2

Detailed Description

OBJECTIVES:

Determine whether interferon alfa in combination with imatinib mesylate adds to the hematologic, cytogenetic, and molecular response rates in patients with chronic phase chronic myelogenous leukemia that is newly diagnosed or has not achieved a complete cytogenetic response to imatinib mesylate alone.

OUTLINE: Patients receive oral imatinib mesylate (STI-571) once daily for 9 months. At 9 months, patients with more than 35% Philadelphia chromosome-positive (Ph+) cells in bone marrow receive oral STI-571 twice daily for 3 more months. At 12 months, patients with more than 35% Ph+ cells in bone marrow receive oral STI-571 once daily and interferon alfa subcutaneously once daily. Treatment continues for at least 1 year in the absence of disease progression or unacceptable toxicity. Patients with an appropriate HLA-matched donor may choose to have a bone marrow transplantation at any time during the study.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 80 patients (60 without an HLA-matched donor and 20 with an HLA-matched donor) will be accrued for this study within 5 years.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Open Label Study to Determine Safety and Efficacy of Interferon-alpha in Combination With Imantinib Mesylate (Gleevec) in Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Not Achieved a Complete Cytogenetic Response to Gleevec as a Single Agent

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Oct 1, 2003

Actual Study Completion Date :

Oct 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of chronic phase chronic myelogenous leukemia
Cytogenetically confirmed Philadelphia chromosome-positive disease or other variant of t(9;22)
No secondary chromosomal abnormalities
No more than 10% blasts in bone marrow
Newly diagnosed OR
Received prior imatinib mesylate as a single agent for no more than the past 9 months without achieving a complete cytogenetic response
No evidence of extramedullary involvement except nodes, liver, or spleen

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

ECOG 0-3

Life expectancy

Not specified

Hematopoietic

Platelet count greater than 100,000/mm^3
Absolute neutrophil count greater than 1,500/mm^3

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN)
SGOT no greater than 2 times ULN
INR no greater than 1.5 times ULN*
PTT no greater than 1.5 times ULN* NOTE: * Except patients on anticoagulants

Renal

Creatinine no greater than 2 times ULN

Other

Considered potentially reliable
No history of noncompliance to medical regimens
No other active malignancy requiring chemotherapy or radiotherapy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier-method contraception during and for at least 3 months after study