Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors
Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors
RATIONALE: Thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to
 the tumor.

 PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who
 have metastatic neuroendocrine tumors.
OBJECTIVES:

 -  Determine the safety and efficacy of thalidomide in patients with metastatic low-grade
 neuroendocrine tumors.

 OUTLINE: Patients receive oral thalidomide once daily on weeks 1-8. Courses repeat every 8
 weeks in the absence of disease progression or unacceptable toxicity.

 PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed low-grade neuroendocrine tumors

 -  Carcinoid tumors

 -  Islet cell tumors

 -  Metastatic disease

 -  Progression of disease within past 4 weeks by radiological evidence

 -  At least 1 bidimensionally measurable lesion by CT scan or MRI

 -  Bone metastasis not considered measurable if only site of disease

 -  No active brain metastases

 PATIENT CHARACTERISTICS:

 Age:

 -  Not specified

 Performance status:

 -  Karnofsky 70-100%

 Life expectancy:

 -  More than 3 months

 Hematopoietic:

 -  WBC at least 3,000/mm^3

 -  Absolute neutrophil count at least 1,500/mm^3

 -  Platelet count at least 100,000/mm^3

 Hepatic:

 -  Bilirubin normal

 -  AST no greater than 2.5 times upper limit of normal (ULN)

 Renal:

 -  Creatinine no greater than 1.5 times ULN OR

 -  Creatinine clearance at least 50 mL/min

 Other:

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use 2 forms of effective contraception for 4 weeks before,
 during, and for 4 weeks after study

 -  No grade 2 or greater neuropathy

 -  No other clinical circumstances that would preclude study

 -  No other prior malignancy except:

 -  Non-melanoma skin cancer

 -  Other cancer that has been curatively treated, has had no evidence of recurrence
 within the past 5 years, and is at low risk for recurrence

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  No prior thalidomide

 -  No concurrent interferon

 Chemotherapy:

 -  No concurrent chemotherapy

 Endocrine therapy:

 -  Not specified

 Radiotherapy:

 -  At least 4 weeks since prior radiotherapy

 -  No concurrent radiotherapy

 Surgery:

 -  At least 4 weeks since prior major surgery

 Other:

 -  No more than 1 prior systemic therapy regimen

 -  At least 4 weeks since prior systemic therapy regimen

 -  No other concurrent therapeutic agent