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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.
Steven P. Treon, MD, MA, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|