NCT00575965

Simvastatin in Waldenstrom's Macroglobulinemia

Phase II Study of Simvastatin in Waldenstrom's Macroglobulinemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study seeks to find new ways to treat people with Waldenstrom's Macroglobulinemia (WM). The study is for participants with slow growing WM who otherwise might not need therapy for at least 3-6 months. Simvastatin is a drug approved by the FDA for lowering cholesterol. In test tube studies the study drug appears to have direct anti-cancer effect against WM tumor cells and mast cells.

Detailed description

OBJECTIVES: To define objective response, time to progression and safety of Simvastatin in Waldenström's Macroglobulinemia. STATISTICAL DESIGN: For this phase II study, a single-stage design is used to evaluate the efficacy of Simvastatin. With a target enrollment of 30 participants, the 95% exact confidence bounds surrounding the response estimate will be no wider than +/- 19%.

Conditions

• Waldenstrom's Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Simvastatin	Oral tablets taken daily

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2007-12-18
• Last updated: 2015-12-16
• Results posted: 2015-12-16

Locations

1 site across 1 country: United States