Status:
TERMINATED
Imatinib Mesylate in Treating Patients With Myelofibrosis
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 min...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00245128
Start Date
August 1 2005
End Date
October 1 2011
Last Update
January 13 2012
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098