Sildenafil Citrate in Waldenstrom's Macroglobulinemia

Completed · Phase 2

Conditions studied: Waldenstrom's Macroglobulinemia

In brief

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.

Key facts

Study ID

NCT00165295

Run by

Dana-Farber Cancer Institute

People needed

30

Starts

2005-09-01

Expected to finish

2007-06-01

Last updated by the study team

2011-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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