A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Matthew H. Kulke, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Beth Israel Deaconness Medical Center||Boston, Massachusetts 02215|