Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00027638


Primary Contact:

Study Chair
Leonard B. Saltz, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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