Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Thalidomide

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