Neuroendocrine Tumor
Conditions
Keywords
thalidomide, temodar, metastatic neuroendocrine tumor, unresectable neuroendocrine tumor
Brief summary
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
* 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.
Interventions
DRUGThalidomide
DRUGTemodar
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate overall response and progression free survival of this patient population | — |
| to evaluate the safety of temodar and thalidomide. | — |
Countries
United States
Outcome results
None listed