Thalidomide, Prednisone, and Cyclophosphamide in Treating Patients With Myelofibrosis and Myeloid Metaplasia

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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 effects and how well giving thalidomide together with prednisone and cyclophosphamide works in treating patients with myelofibrosis and myeloid metaplasia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Prednisone; Thalidomide

Criteria

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