NCT00015821

Thalidomide in Treating Patients With Myelofibrosis

A Pilot Study of Thalidomide as an Inhibitor of Angiogenesis in the Treatment of Myelofibrosis With Myeloid Metaplasia (MMM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of thalidomide in treating patients who have myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To investigate whether thalidomide, a potent inhibitor of angiogenic and fibrogenic growth factors, is an effective therapeutic agent in patients with MMM. Specifically, to assess whether thalidomide improves anemia and/or organomegaly in patients with MMM. II. To assess the effects of thalidomide on the myelofibrotic stroma with respect to microvascular architecture and angiogenesis, collagen and reticulin deposition, and the expression of the mediating growth factors bFGF, TGF-b, and PDGF, and their respective receptors. OUTLINE: This is a multicenter study. 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. Patients are followed every 6 months until 5 years from study entry.

Conditions

• Primary Myelofibrosis

Interventions

Type	Name	Description
DRUG	thalidomide	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-05-01
• Primary completion: 2007-12-01
• First posted: 2003-05-23
• Last updated: 2013-10-08

Locations

1 site across 1 country: United States