Simvastatin in Waldenstrom's Macroglobulinemia - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00575965

Purpose

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.

Condition	Intervention	Phase
Waldenstrom's Macroglobulinemia	Drug: Simvastatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Simvastatin in Waldenstrom's Macroglobulinemia

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer

Drug Information available for: Simvastatin

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Oral tablets taken daily

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575965

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

Principal Investigator:

Steven Treon, MD, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Steven Treon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00575965 History of Changes
Other Study ID Numbers:	07-175
Study First Received:	December 16, 2007
Last Updated:	June 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

simvastatin

Additional relevant MeSH terms:

Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012