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Sildenafil Citrate in Waldenstrom's Macroglobulinemia

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165295
First received: September 9, 2005
Last updated: June 23, 2011
Last verified: June 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:


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   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00165295     History of Changes
Other Study ID Numbers: 05-087
Study First Received: September 9, 2005
Last Updated: June 23, 2011

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 Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents

ClinicalTrials.gov processed this record on July 24, 2017