Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors

Conditions
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Neuroendocrine Tumor

Intervention / Treatment
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* Drug: Thalidomide
* Drug: Temodar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thalidomide|nan|
|Drug: Temodar|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate overall response and progression free survival of this patient population |  |  | 
| to evaluate the safety of temodar and thalidomide. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thalidomide, temodar, metastatic neuroendocrine tumor, unresectable neuroendocrine tumor