Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165230
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2005-09-09
Brief Title:
Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2009-04
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 find out what effects good or bad that thalidomide and temodar have on patients with neuroendocrine tumors
Detailed Description:
Patients will receive thalidomide orally once daily continuously unless they experience significant side effects Temodar is given orally once a day for one week followed by a one week break period This one week onone week off schedule will continue for the duration of treatment unless there are significant side effects
After eight weeks 2 cycles a CT scan will be performed to see how the treatment has affected the patients tumor Patients will continue taking the study drug unless there is evidence of tumor growth
Regular blood tests will be done weekly during the first two months to make sure that the treatment is not resulting in serious side effects If there are no side effects during the first two months the blood tests may decrease in frequency to every two weeks
Immediately after the patient has completed the study they will be evaluated by physical exam blood work and a CT scan The follow-up will consist of clinic visits and phone calls every 3 months
After eight weeks 2 cycles a CT scan will be performed to see how the treatment has affected the patients tumor Patients will continue taking the study drug unless there is evidence of tumor growth
Regular blood tests will be done weekly during the first two months to make sure that the treatment is not resulting in serious side effects If there are no side effects during the first two months the blood tests may decrease in frequency to every two weeks
Immediately after the patient has completed the study they will be evaluated by physical exam blood work and a CT scan The follow-up will consist of clinic visits and phone calls every 3 months
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