Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT00165295
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date September 2005
Completion date June 2007

See also
  Status Clinical Trial Phase
Completed NCT02566265 - Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients Phase 2
Completed NCT00422656 - Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00150462 - Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Phase 1
Terminated NCT00142168 - CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia Phase 2
Suspended NCT02439138 - Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Phase 2
Completed NCT01470196 - Carfilzomib, Rituximab and Dexamethasone in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00250926 - Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Phase 2
Terminated NCT03225716 - A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia Phase 1
Terminated NCT01744912 - Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies Phase 1
Completed NCT02363439 - Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401 Phase 1/Phase 2
Completed NCT00976248 - Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia Phase 2
Terminated NCT00575965 - Simvastatin in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00919139 - S0309, Repository: Blood/Bone Marrow From Pts. With Myeloma, WM, Amyloidosis, or MGUS. N/A
Completed NCT01614821 - Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia Phase 2
Active, not recruiting NCT01078974 - Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia Phase 1
Completed NCT00481871 - Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies Phase 1/Phase 2
Completed NCT00142116 - Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT02092909 - Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia Phase 1/Phase 2
Completed NCT00807677 - A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies Phase 1
Completed NCT01046006 - Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstrom's Macroglobulinemia Phase 2