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Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors - Article


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Carcinoid Tumor, Childhood


Clinical Trial: Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

This study is no longer recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
gastrointestinal carcinoid tumor
Islet Cell Carcinoma
pulmonary carcinoid tumor
 Drug: thalidomide
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: growth factor antagonist therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Carcinoid Tumors;   Digestive Diseases;   Endocrine Diseases;   Lung Cancer;   Pancreatic Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Thalidomide in Patients With Metastatic Low-Grade Neuroendocrine Tumors

Further Study Details: 

OBJECTIVES:

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

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:


Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069051; MSKCC-01027; NCI-G01-2029
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  December 7, 2001
ClinicalTrials.gov Identifier:  NCT00027638
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 11, 2008



Page Updated: September 23, 2004
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