Status:
COMPLETED
Sildenafil Citrate in Waldenstrom's Macroglobulinemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Conditions:
Waldenstrom's Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 s...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00165295
Start Date
September 1 2005
End Date
June 1 2007
Last Update
June 27 2011
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115