Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
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The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.
Condition or disease
Drug: ThalidomideDrug: Temodar
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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