Status:
COMPLETED
Thalidomide, Prednisone, and Cyclophosphamide in Treating Patients With Myelofibrosis and Myeloid Metaplasia
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Secondary Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen symptoms caused by myelofibrosis and myeloid metaplasia. PURPOSE: This phase II trial is studying the side effec...
Detailed Description
OBJECTIVES: Primary * Determine the benefit of thalidomide, prednisone, and cyclophosphamide in alleviating disease-associated anemia, thrombocytopenia, and/or splenomegaly in patients with myelofib...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed myelofibrosis with myeloid metaplasia (MMM) of any of the following subtypes:
- Agnogenic myeloid metaplasia
- Post-polycythemic myeloid metaplasia
- Post-thrombocythemic myeloid metaplasia
- Must have 1 of the following MMM-related conditions:
- Anemia, defined as hemoglobin \< 10 g/dL
- Iron deficiency must be excluded as cause
- Thrombocytopenia, defined as platelet count \< 100,000/mm³
- Palpable hepatomegaly or splenomegaly
- No evidence of myelofibrosis-associated conditions in the bone marrow, including any of the following:
- Metastatic carcinoma
- Lymphoma
- Myelodysplasia
- Hairy cell leukemia
- Mast cell disease
- Acute leukemia (including M7 type)
- Acute myelofibrosis
- No chromosomal translocation t(9:22) or bcr-abl as determined by bone marrow chromosome analysis or peripheral blood fluorescent in situ hybridization (FISH) analysis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Absolute neutrophil count ≥ 750/mm³
- Bilirubin ≤ 2 times upper limit of normal (ULN), unless elevation due to MMM
- AST ≤ 5 times ULN, unless elevation due to MMM
- Creatinine ≤ 2.5 mg/dL
- No uncontrolled infection, including tuberculosis
- No known history of positive purified protein derivative (PPD) untreated by isoniazid therapy
- Positive PPD with normal chest X-ray and completion of full-course isoniazid therapy allowed
- No federal medical center inmates or other incarcerated patients
- No peripheral neuropathy ≥ grade 2
- No comorbid condition in which the use of study therapy is felt to be potentially harmful
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of effective contraception
- PRIOR CONCURRENT THERAPY:
- No chemotherapy (e.g., hydroxyurea, myelosuppressive therapy) within the past 14 days
- Prior splenectomy for MMM allowed
- No concurrent hematopoietic growth factors
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00445900
Start Date
October 1 2004
End Date
October 1 2006
Last Update
March 17 2011
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