Simvastatin in Waldenstrom's Macroglobulinemia

NCT ID: NCT00575965

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-12-31

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%.

Conditions

Waldenstrom's Macroglobulinemia

Keywords

simvastatin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simvastatin

Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression.

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

Oral tablets taken daily

Interventions

Simvastatin

Oral tablets taken daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Clinicopathological diagnosis of Waldenstrom's macroglobulinemia
• Measurable disease
• Slowly progressing disease not requiring therapy for at least 3-6 months and who do not meet consensus panel criteria for initiation of therapy
• ECOG Performance status of 0 or 1
• Adequate organ function as defined in the protocol
• Patients should agree to avoid grapefruit juice which is a major inhibitor of CYP 3A4

Exclusion Criteria

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than four weeks earlier
• Patients who have had rituximab within 3 months prior to entering the study
• Patients who have taken any Statin in the past
• Patients who take cyclosporin, danazol, or gemfibrozil will be excluded
• Prior history of rhabdomyolysis
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
• Pregnant or breastfeeding women
• HIV-positive
• Patients who take verapamil will be excluded
• Patients with active or history of liver disease
• Patients who consume more than three alcoholic beverages per day

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Steven P. Treon, MD, PhD

Director, Bing Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Treon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

07-175

Identifier Type: -

Identifier Source: org_study_id