Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00165230|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumor||Drug: Thalidomide Drug: Temodar||Phase 2|
- 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 on/one 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 patient's 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 Type :||Interventional (Clinical Trial)|
|Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
- To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
- To evaluate overall response and progression free survival of this patient population
- to evaluate the safety of temodar and thalidomide.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165230
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconness Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Matthew H. Kulke, MD||Dana-Farber Cancer Institute|