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Sildenafil Citrate in Waldenstrom's Macroglobulinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165295
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Waldenstrom's Macroglobulinemia Drug: Sildenafil citrate (Viagra) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Sildenafil Citrate in Waldenstrom's Macroglobulinemia
Study Start Date : September 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007





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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165295


Locations
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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
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Principal Investigator: Steven P. Treon, MD, MA, PhD Dana-Farber Cancer Institute
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ClinicalTrials.gov Identifier: NCT00165295    
Other Study ID Numbers: 05-087
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
Keywords provided by Dana-Farber Cancer Institute:
sildenafil citrate
Viagra
Waldenstrom's macroglobulinemia
Additional relevant MeSH terms:
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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
Sildenafil Citrate
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents