Spots Global Cancer Trial Database for Simvastatin in Waldenstrom's Macroglobulinemia

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Trial Identification

Brief Title: Simvastatin in Waldenstrom's Macroglobulinemia

Official Title: Phase II Study of Simvastatin in Waldenstrom's Macroglobulinemia

Study ID: NCT00575965

Conditions

Waldenstrom's Macroglobulinemia

Interventions

Simvastatin

Study Description

Brief 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%.