Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastrointestinal Carcinoid Tumor, Islet Cell Tumor, Lung Cancer, Neoplastic Syndrome

Intervention / Treatment
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* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic gastrointestinal carcinoid tumor, recurrent gastrointestinal carcinoid tumor, gastrinoma, insulinoma, recurrent islet cell carcinoma, WDHA syndrome, somatostatinoma, pancreatic polypeptide tumor, glucagonoma, pulmonary carcinoid tumor