Sildenafil Citrate in Waldenstrom's Macroglobulinemia - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Beth Israel Deaconess Medical Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165295

Purpose

The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra) has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can destroy WM cells.

Condition	Intervention	Phase
Waldenstrom's Macroglobulinemia	Drug: Sildenafil citrate (Viagra)	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 Sildenafil Citrate in Waldenstrom's Macroglobulinemia

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer

Drug Information available for: Citric acid Sildenafil Sildenafil citrate Sodium Citrate

U.S. FDA Resources

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

Primary Outcome Measures:

To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.

Estimated Enrollment:	30
Study Start Date:	September 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Sildenafil will be given orally (at home) at a reduced dose for the first week, then each week for 3 more weeks, the dose will be increased. If the patient has no major side effects, then they will receive the maximal dose for 2 years. If they have major side effects, then the dose of the drug might be lowered or the drug stopped.
Sildenafil will be continued until their is disease progression or serious side effects.
While patients are receiving sildenafil, they will be seen in the clinic on months 1,2,9,15 and 21 for blood tests and a subject questionnaire. They will also be seen on months 3,6,12,18 and 24 for a physical exam, blood test, physical assessment test, CT scans of chest, abdomen and pelvis, and a subject questionnaire.
At the end of the study (month 24) a physical exam, blood tests, physical assessment test and a questionnaire will be conducted.
Follow-up includes clinic visits at month 27,33,39 and 45 for blood tests and a questionnaire as well as visits at month 30,36,42 and 48 for physical exam, blood tests, physical assessment test, bone marrow aspirate and biopsy, CT scans of chest, abdomen and pelvis, and a questionnaire.

Eligibility

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

Criteria

Inclusion Criteria:

Clinicopathological diagnosis of Waldenstrom's macroglobulinemia
Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of > 2 times the upper limit of each institution's normal value
Slowly progressing disease not requiring therapy for at least 3-6 months
ECOG performance status 0,1 or 2
Total bilirubin < 2 x ULN
SGOT < 3 x ULN
Creatinine < 2 x ULN

Exclusion Criteria:

Pregnant or breast-feeding women
Patients who are using organic nitrates or alpha-blockers
Grade III/IV cardiac problems
Resting hypotension (BP < 90/50) or hypertension (BP > 170/110)
Cardiac failure or coronary artery disease causing unstable angina
Evidence of left ventricular outflow obstruction
Impaired autonomic control of blood pressure
Sickle cell anemia
History of priapism
Severe and/or uncontrolled medical disease
Known chronic liver disease
Currently using ritonavir
History of retinal pigmentosa

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165295

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Steven P. Treon, MD, MA, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00165295 History of Changes
Other Study ID Numbers:	05-087
Study First Received:	September 9, 2005
Last Updated:	June 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

sildenafil citrate
Viagra
Waldenstrom's macroglobulinemia

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
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012