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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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE September 2005
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sildenafil Citrate in Waldenstrom's Macroglobulinemia
Official Title  ICMJE Phase II Study of Sildenafil Citrate in Waldenstrom's Macroglobulinemia
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Waldenstrom's Macroglobulinemia
Intervention  ICMJE Drug: Sildenafil citrate (Viagra)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00165295
Other Study ID Numbers  ICMJE 05-087
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Beth Israel Deaconess Medical Center
Investigators  ICMJE
Principal Investigator: Steven P. Treon, MD, MA, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP