Thalidomide In Treating Patients With Metastatic Neuroendocrine Tumors

Study Overview

Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

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.

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.

Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Lung Cancer
Neoplastic Syndrome

DRUG: thalidomide

MSKCC-01027
CDR0000069051 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))
NCI-G01-2029

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-12-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-17
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-18
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2013-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

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

Not specified

Karnofsky 70-100%

More than 3 months

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Bilirubin normal
AST no greater than 2.5 times upper limit of normal (ULN)

Creatinine no greater than 1.5 times ULN OR
Creatinine clearance at least 50 mL/min

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

No prior thalidomide
No concurrent interferon

No concurrent chemotherapy

Not specified

At least 4 weeks since prior radiotherapy
No concurrent radiotherapy

At least 4 weeks since prior major surgery

No more than 1 prior systemic therapy regimen
At least 4 weeks since prior systemic therapy regimen
No other concurrent therapeutic agent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Leonard B. Saltz, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record