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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
OHSU Knight Cancer Institute
Portland, Oregon, United States
Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy
A major response = transfusion independent or a\>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks. Minor response= \> 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period.
Time frame: At 3,6, and 12 months of therapy
Reduction in Marrow Fibrosis and Decrease in Spleen Size
Time frame: After 6 and 12 months of therapy
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