Expired Study
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New York, New York 10021


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.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

Official Title:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:


Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

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

Study Dates

Start Date:March 2001
Completion Date:December 2003
Completion Type:Actual
Primary Completion Date:December 2003
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 17, 2013
First Received Date:December 7, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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