A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
18 Years
N/A
Both
Neuroendocrine Tumor
Trial Information
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
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.
Inclusion Criteria:
- Histologically confirmed locally unresectable or metastatic neuroendocrine tumor
excluding small cell carcinoma
- Prior treatment with chemoembolization or cryotherapy is allowed
- Radiotherapy is allowed if completed more than 4 weeks prior to study.
- Measurable disease as defined by RECIST criteria
- Age greater than or equal to 18 years.
- ECOG performance status of less than or equal to 2
- ANC >1,500/mm3
- Platelet Count > 100,000/mm3
- Hemoglobin > 9 g/dl
- Serum creatinine < 1.5 x ULN
- Total bilirubin < 2 x ULN
- SGOT and SGPT < 2 x ULN
- Alkaline phosphatase < 2 x ULN
- Life expectancy of greater than 12 weeks
Exclusion Criteria:
- Clinically symptomatic central nervous system metastases or carcinomatous meningitis
- Myocardial infarction in past 6 months
- Major surgery in past two weeks
- Uncontrolled serious medical or psychiatric illness
- Insufficient recovery from all active toxicities of prior therapies
- Active nonmalignant systemic disease
- Frequent vomiting or medical condition that could interfere with oral medication
intake
- Known HIV positivity or AIDS-related illness
- Pregnant or nursing women
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Principal Investigator
Matthew H. Kulke, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
02-011
NCT ID:
NCT00165230
Start Date:
May 2002
Completion Date:
July 2006
Related Keywords:
- Neuroendocrine Tumor
- thalidomide
- temodar
- metastatic neuroendocrine tumor
- unresectable neuroendocrine tumor
- Neuroendocrine Tumors
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Beth Israel Deaconness Medical Center | Boston, Massachusetts 02215 |
