Sildenafil Citrate in Waldenstrom's Macroglobulinemia

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Beth Israel Deaconess Medical Center
• Treatments: Citric Acid; Sildenafil Citrate

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