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

This study has been terminated.
(due to slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Meranze, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00466856
First received: April 25, 2007
Last updated: May 17, 2012
Last verified: May 2012

April 25, 2007
May 17, 2012
December 2003
October 2006   (final data collection date for primary outcome measure)
Tumor response [ Time Frame: at 1 year or until intervening death ] [ Designated as safety issue: No ]
  • Disease progression
  • Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
  • Toxicity as measured by CTC v3.0
  • Health-related quality of life
Complete list of historical versions of study NCT00466856 on ClinicalTrials.gov Archive Site
  • Toxicity as measured by CTC v3.0 [ Time Frame: at 1 year or until intervening death ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Head and Neck Cancer
  • Islet Cell Tumor
  • Metastatic Cancer
  • Pheochromocytoma
  • 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
    Other Name: octreotide
  • Radiation: yttrium Y 90 resin microspheres
    radiation
    Other Name: octreotide
Experimental: Sir-Spheres
Interventions:
  • Drug: octreotide acetate
  • Radiation: yttrium Y 90 resin microspheres
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
October 2007
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00466856
VICC GI 0365, VU-VICC-GI-0365
Yes
Steven Meranze, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Steven G. Meranze, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP