Phase II Clinical Trial of Sildenafil Citrate in WM
Institution: Dana-Farber Cancer Institute
Physician: Steven P. Treon, MD, MA, PhD
This is a Phase II study of sildenafil citrate, commonly known as Viagra. This trial will evaluate how well and how safe sildenafil citrate works as a treatment for Waldenstrom's macroglobulinemia. The drug works by blocking the function of several proteins necessary for survival in cancer cells. Tests have shown that the drug may be effective in destroying WM cells and Mast Cells, which support WM cells.
Participants will begin treatment at a reduced dose for the first week, then each week for 3 additional weeks, the dose will be increased. If there are no major side effects or disease progression, participants will continue on the maximal dose for up to 2 years. If the disease progresses, or if a participant were to experience significant side effects, his/her doctor may decide to stop the study drug.
Patients may undergo monitoring procedures while on this trial such as, blood tests, collection of urine samples, physical exams, medical history reviews, vital signs measures (heart rate and blood pressure), answering questionnaires, electrocardiogram (ECG/EKG, a tracing of the electrical activity of the heart), bone marrow/tumor biopsies; and various radiological tests to monitor the progress of the patient's cancer and health.
Patients will be asked to return to the clinic for follow-up tests every 3 months for 2 years.