Overview

This trial is active, not recruiting.

Condition waldenstrom's macroglobulinemia
Treatment simvastatin
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Start date November 2007
End date August 2011
Trial size 30 participants
Trial identifier NCT00575965, 07-175

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To define objective response (ORR, CR, PT, MR), time to progression (TTP) and safety of simvastatin therapy in patients with slow progressing Waldenstrom's macroglobulinemia.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Simvastatin in Waldenstrom's Macroglobulinemia
Principal investigator Steven Treon, MD, PhD
Description - Treatment in this study involves starting at a reduced dose for the first week, and moves up in dose each week for the following three weeks. At which time the participant will continue to take the same dose daily. The study drug is taken orally once a day in the morning. - If participants have no major side effects, they will continue on the maximal dose for 2 years. If they experience major side effects, then the dose of the drug might be lowered or the drug stopped. The study drug will continue until the participants disease gets worse. - During the treatment period participants will come in for routine visits to have a physical exam and laboratory tests. CT scans of the chest, abdomen and pelvis and bone marrow aspirate and biopsy may also be performed.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.