Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers)
Inclusion Criteria
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
