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Phase II Study of Sildenafil Citrate in Waldenstrom's Macroglobulinemia

Phase 2
18 Years
Not Enrolling
Waldenstrom's Macroglobulinemia

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Trial Information

Phase II Study of Sildenafil Citrate in Waldenstrom's Macroglobulinemia

- 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

- 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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.

Principal Investigator

Steven P. Treon, MD, MA, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2005

Completion Date:

June 2007

Related Keywords:

  • Waldenstrom's Macroglobulinemia
  • sildenafil citrate
  • Viagra
  • Waldenstrom's macroglobulinemia
  • Waldenstrom Macroglobulinemia



Dana-Farber Cancer Institute Boston, Massachusetts  02115