Simvastatin in Waldenstrom's Macroglobulinemia
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Waldenstrom's Macroglobulinemia
Intervention: Simvastatin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s):
Steven Treon, MD, PhD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
Overall contact:
Steven Treon, MD, PhD, Phone: 617-632-2681, Email: steven_treon@dfci.harvard.edu
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.
Clinical Details
Official title: Phase II Study of Simvastatin in Waldenstrom's Macroglobulinemia
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Steven Treon, MD, PhD, Phone: 617-632-2681, Email: steven_treon@dfci.harvard.edu
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Additional Information
Starting date: November 2007
Ending date: December 2009
Last updated: April 23, 2009
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