Imatinib Mesylate in Treating Patients With Myelofibrosis

NCT ID: NCT00245128

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2011-10-31

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well it works in treating patients with myelofibrosis.

Detailed Description

OBJECTIVES:

Primary

• Determine the safety, efficacy, and tolerability of imatinib mesylate in patients with myelofibrosis with myeloid metaplasia.
• Determine the 3-, 6-, and 12-month major and minor erythroid response rates in patients treated with this drug.

Secondary

• Determine reduction in marrow fibrosis in patients treated with this drug.
• Determine decrease in spleen size in patients treated with this drug.

OUTLINE: This is a multicenter, open-label, nonrandomized, pilot study.

Patients receive oral imatinib mesylate once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients who do not experience a minor erythroid response or a 50% reduction in spleen size after 6 months of treatment are removed from the study. Patients experiencing clinical benefit (e.g., ongoing erythroid response) after 1 year of treatment may continue treatment with imatinib mesylate as above at the discretion of the principal investigator.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Conditions

Chronic Myeloproliferative Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

imatinib mesylate

Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of myelofibrosis with myeloid metaplasia (MMM), defined by all of the following:

• Leukoerythroblastic blood picture
• Fibrosis involving > 1/3 sectional area of bone marrow biopsy
• Splenomegaly (unless patient has undergone prior splenectomy)
• Philadelphia chromosome negative
• No myelodysplastic syndrome
• No systemic disorders associated with marrow fibrosis
• Red blood cell transfusion dependent, defined by 1 of the following:

• Patient has required ≥ 2 units of red blood cells every 4 weeks within the past 8 weeks
• Hemoglobin ≤ 8 g/dL on ≥ 3 occasions (≥ 2 weeks apart ) over the past 8 weeks
• No evidence of disease transformation to acute myelogenous leukemia, defined as > 20% blasts in bone marrow and/or peripheral blood

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3
• Platelet count > 50,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST or ALT ≤ 2 times ULN (unless due to extramedullary hematopoiesis in the liver)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No New York Heart Association grade III-IV heart disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment
• No serious, uncontrolled medical condition
• No patients who are considered potentially unreliable or with a history of noncompliance to medical regimens

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 2 weeks since prior interferon alfa

Chemotherapy

• No concurrent chemotherapy except hydroxyurea to control elevated blood counts

Endocrine therapy

• More than 4 weeks since prior corticosteroids, danazol, or other androgens for MMM

Other

• More than 4 weeks since other prior treatment for MMM
• No other concurrent experimental drug therapy for MMM

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Mauro, MD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-541

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-HEM-01071-L

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000445435

Identifier Type: -

Identifier Source: org_study_id