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Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027638
  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.


Condition Intervention Phase
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Lung Cancer
Neoplastic Syndrome
Drug: thalidomide
Phase II

MedlinePlus related topics: Cancer Carcinoid Tumors Lung Cancer
Drug Information available for: Thalidomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027638

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Leonard B. Saltz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069051, MSKCC-01027, NCI-G01-2029
Study First Received: December 7, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00027638  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
gastrinoma
insulinoma
recurrent islet cell carcinoma
WDHA syndrome
somatostatinoma
pancreatic polypeptide tumor
glucagonoma
pulmonary carcinoid tumor

Study placed in the following topic categories:
Thoracic Neoplasms
Thalidomide
Gastrointestinal Diseases
Pancreatic Neoplasms
Pancreatic Polypeptide
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Endocrine Gland Neoplasms
Digestive System Neoplasms
Carcinoma, Islet Cell
Serotonin Syndrome
Insulinoma
Endocrine System Diseases
Adenoma, Islet Cell
Malignant Carcinoid Syndrome
Carcinoid syndrome
Recurrence
Neuroendocrine Tumors
Carcinoma
Carcinoid tumor
Neuroectodermal Tumors
Gastrinoma
Digestive System Diseases
Lung Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Carcinoid Tumor
Endocrinopathy

Additional relevant MeSH terms:
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Disease
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Syndrome
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 16, 2009