Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors

Overview

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors.

Full Title of Study: “Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2006

Detailed Description

OBJECTIVES: Primary – Determine tumor response to selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with progressive liver metastases from neuroendocrine tumors. Secondary – Determine the toxicity of this treatment in these patients. – Determine the symptomatic relief of patients treated with this regimen. – Determine the health-related quality of life of patients receiving this treatment. OUTLINE: Patients have an catheter placed into the hepatic artery percutaneously through the groin and then undergo selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) via the catheter on day 1. Patients also receive octreotide acetate IV 1 hour prior to, during, and 2 hours after Sir-Spheres® injection. Patients may undergo above treatment in another lobe of the liver (if each lobe is treated separately) 4 weeks later. Patients undergo functional performance, health-related quality of life, and symptom severity assessment prior to initial treatment and after completion of study treatment. After completion of study treatment, patients are followed periodically for at least 1 year. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Interventions

  • Drug: octreotide acetate
    • Lung/liver Ratio Dose of SIR-Spheres <10% Administer full dose of SIR-Spheres 10% to 15% Reduce dose of SIR-Spheres by 20% 16% to 20% Reduce dose of SIR-Spheres by 40% >20% Do not give SIR-Spheres
  • Radiation: yttrium Y 90 resin microspheres
    • radiation

Arms, Groups and Cohorts

  • Experimental: Sir-Spheres

Clinical Trial Outcome Measures

Primary Measures

  • Tumor response
    • Time Frame: at 1 year or until intervening death

Secondary Measures

  • Toxicity as measured by CTC v3.0
    • Time Frame: at 1 year or until intervening death
  • Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
    • Time Frame: at 1 year or until intervening death
    • The Carcinoid Symptom Severity Scale is a self-report instrument that addresses the severity and frequency of symptoms and their impact on daily living.
  • Patient report of Health-related quality of life (HRQOL)
    • Time Frame: at 1 year or until intervening death
    • HRQOL will be determined via the Medical Outcome Study 36-item short form, which includeds 8 individual scales, physical and mental component summary scores and is normed to both health and clinical populations.

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Pathologically confirmed neuroendocrine tumor metastatic to the liver – Well-differentiated or moderately well-differentiated neuroendocrine tumors – Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan – Symptomatic disease, meeting one of the following criteria: – Refractory carcinoid symptoms, defined as Carcinoid Symptom Severity scale > 2 despite use of octreotide acetate at ≥ 200 mcg subcutaneously three times daily (or 20 mg intramuscularly once monthly) for ≥ 4 weeks – Evidence of radiographic progression with either of the following manifestations: – Moderate-severe right upper quadrant pain and unintentional weight loss > 10% – Decline in Karnofsky performance status > 10 points – At least a 20% increase in the sum of the longest diameters of target lesions in the liver within the past 12 months – No more than 75% replacement of normal liver by neuroendocrine tumor – No more than 20% arteriovenous lung shunting on a technetium Tc 99m macro-aggregated albumin nuclear scan – No equivocal, nonmeasurable, or nonevaluable liver metastasis PATIENT CHARACTERISTICS: – Karnofsky performance status 50-100% – Life expectancy ≥ 6 months – Not pregnant or nursing – Negative pregnancy test – Fertile patients must use effective contraception – Creatinine ≤ 1.5 mg/dL – Bilirubin ≤ 2.0 mg/dL – Albumin ≥ 3.0 g/dL – Absolute granulocyte count ≥ 1,500/mm³ – Platelet count ≥ 65,000/mm³ – Hemoglobin > 9.0 g/dL – INR ≤ 1.4 – No hepatic arterial anatomy that would preclude the administration of study treatment into the liver – No nonmalignant disease that would preclude study participation – No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix PRIOR CONCURRENT THERAPY: – Prior surgery, chemotherapy, or locally ablative technique for the liver cancer allowed – No prior radiotherapy to the upper abdomen that includes the liver in the treatment field – No investigational drug or agent/procedure (i.e., participation in another clinical trial) within the past 4 weeks – No other specific anticancer treatment (other than octreotide acetate) during and for 3 months after completion of study therapy
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Vanderbilt-Ingram Cancer Center
    • Collaborator
      • National Cancer Institute (NCI)
    • Provider of Information About this Clinical Study
      • Principal Investigator: Steven Meranze, MD, Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist – Vanderbilt-Ingram Cancer Center
    • Overall Official(s)
      • Steven G. Meranze, MD, Principal Investigator, Vanderbilt-Ingram Cancer Center

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