Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165295
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2005-09-09
Brief Title:
Sildenafil Citrate in Waldenstroms Macroglobulinemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of Sildenafil Citrate in Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects good or bad that sildenafil Viagra has on patients with slow growing Waldenstroms 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 12915 and 21 for blood tests and a subject questionnaire They will also be seen on months 361218 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 273339 and 45 for blood tests and a questionnaire as well as visits at month 303642 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
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 12915 and 21 for blood tests and a subject questionnaire They will also be seen on months 361218 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 273339 and 45 for blood tests and a questionnaire as well as visits at month 303642 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None