Decitabine in Treating Patients With Myelofibrosis

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies the side effects and how well decitabine works in treating patients with myelofibrosis, a cancer of the blood system associated with fibrosis (scar tissue) in the bone marrow that is advanced and for which there is no standard therapy. Decitabine may block the actions of some proteins that are responsible for turning certain genes off in various cancers including myelofibrosis.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine response rate (complete and partial responses and hematological improvement) to decitabine in patients with myelofibrosis. II. To determine the safety of decitabine in patients with myelofibrosis. SECONDARY OBJECTIVES: I. To determine the effects of decitabine on specific epigenetic changes including methylation status of specific target genes and gene re-expression. II. To determine the effect of decitabine on hemoglobin F levels and on the absolute numbers of circulating cluster of differentiation (CD) 34+ progenitor cells and to investigate the potential utility of these markers as a surrogate for biologic activity of decitabine in myeloid metaplasia with myelofibrosis (MMM). OUTLINE: Patients receive decitabine subcutaneously (SC) on days 1-5 and 8-12. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00095784
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	September 29, 2004
Completion date	February 22, 2025

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See also
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