Overview

Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Treatments:
Dacarbazine
Temozolomide
Thalidomide
Criteria
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