Thalidomide in Treating Patients With Myelofibrosis
Primary Myelofibrosis
About this trial
This is an interventional treatment trial for Primary Myelofibrosis
Eligibility Criteria
Inclusion Criteria: Histologically confirmed myelofibrosis with myeloid metaplasia Agnogenic myeloid metaplasia Post-polycythemic myeloid metaplasia Post-thrombocythemic myeloid metaplasia No metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease, acute leukemia (including M7), or acute myelofibrosis No chromosomal translocation t(9;22) or bcr/abl gene rearrangement Presence of reticulin fibrosis in bone marrow and leukoerythroblastosis and dacrocytosis in peripheral blood Presence of anemia (hemoglobin less than 10 g/dL), palpable splenomegaly, or hepatomegaly Performance status - ECOG 0-2 Absolute neutrophil count greater than 750/mm^3 Platelet count less than 400,000/mm^3 WBC less than 50,000/mm^3 Bilirubin no greater than 2 mg/dL (if total bilirubin elevated, direct bilirubin must be normal) AST no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Not pregnant or nursing Negative pregnancy test Fertile women must use at least 1 highly active method AND 1 additional effective method of contraception for at least 4 weeks before study, during study, and for at least 4 weeks after study Fertile men must use effective contraception during study and for at least 4 weeks after study No uncontrolled infection No concurrent condition that would preclude study No peripheral neuropathy At least 1 month since prior interferon, pirfenidone, anagrelide, or epoetin alfa At least 1 month since prior hydroxyurea or other chemotherapy At least 1 month since prior corticosteroids or androgen derivatives
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment (thalidomide)
Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 1 additional year of therapy.