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