Brief Title
Sildenafil Citrate in Waldenstrom's Macroglobulinemia
Official Title
Phase II Study of Sildenafil Citrate in Waldenstrom's Macroglobulinemia
Brief 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.
Detailed Description
- 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 effects.
- 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
To determine response, time to progression and safety for sildenafil citrate therapy in patients with slowly progressing Waldenstrom's macroglobulinemia.
Condition
Waldenstrom's Macroglobulinemia
Intervention
Sildenafil citrate (Viagra)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
September 2005
Completion Date
June 2007
Primary Completion Date
June 2007
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Steven P. Treon, MD, MA, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00165295
Organization ID
05-087
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center
Study Sponsor
Steven P. Treon, MD, MA, PhD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
June 2011