Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine works in treating patients with symptomatic myelofibrosis.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Decitabine

Criteria

DISEASE CHARACTERISTICS:

• Histological confirmation of primary myelofibrosis or post essential thrombocythemic or polycythemic vera myelofibrosis

• Reticulin fibrosis ≥ grade 1

• Evaluable and symptomatic disease worthy of treatment, characterized by ≥ 1 of the following:

• Anemia, defined as hemoglobin < 11 g/dL or erythrocyte transfusion dependence

• Palpable and symptomatic splenomegaly (palpable and symptomatic hepatomegaly is acceptable if previously splenectomized)

• Severe, disease-related constitutional symptoms, including ≥ 1 of the following:

• Severe night sweats

• Fevers

• Weight loss

• Bone pain

• Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics OR prior demonstration of a lack of this translocation

PATIENT CHARACTERISTICS:

• Eastern Co-operative Oncology Group (ECOG) performance status 0-3

• Absolute neutrophil count (ANC) ≥ 1,000/mm³

• Platelet count ≥ 50,000/mm³

• Creatinine ≤ 2.0 mg/dL

• Direct or total bilirubin ≤ 2.0 mg/dL

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN) (≤ 5 times ULN if elevation is attributed to hepatic extramedullary hematopoiesis)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Not incarcerated in a municipality, county, state, or federal prison

• No serious medical condition or psychiatric illness that would preclude signing the informed consent

• No condition that, in the opinion of the treating physician, places the patient at unacceptable risk for study participation or confounds the ability to interpret study data

• Able to adhere to the study visit schedule and other study requirements

PRIOR CONCURRENT THERAPY:

• No other concurrent chemotherapy (e.g., hydroxyurea, thalidomide, interferon alpha, anagrelide, or other myelosuppressive agent) or experimental therapy