Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
Completed · Phase 2
Conditions studied: Neuroendocrine Tumor
In brief
The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.
Key facts
- Study ID
- NCT00165230
- Run by
- Dana-Farber Cancer Institute
- People needed
- 32
- Starts
- 2002-05-01
- Expected to finish
- 2006-07-01
- Last updated by the study team
- 2009-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Beth Israel Deaconness Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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