Thalidomide in Treating Patients With Metastatic Neuroendocrine Tumors

Overview

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.

Full Title of Study: “Phase II Trial Of Thalidomide In Patients With Low Grade Neuroendocrine Tumors (Carcinoid and Islet Cell Cancers)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
  • Study Primary Completion Date: December 2003

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.

Interventions

  • Drug: thalidomide

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: N/A

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Memorial Sloan Kettering Cancer Center
    • Collaborator
      • National Cancer Institute (NCI)
    • Overall Official(s)
      • Leonard B. Saltz, MD, Study Chair, Memorial Sloan Kettering Cancer Center

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