Status:
COMPLETED
Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Neuroendocrine Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00165230
Start Date
May 1 2002
End Date
July 1 2006
Last Update
April 28 2009
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States, 02215