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
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Islet Cell Tumor
Metastatic Cancer
Pheochromocytoma
Drug: octreotide acetate
Radiation: yttrium Y 90 resin microspheres
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Tumor response [ Time Frame: at 1 year or until intervening death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: December 2003
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sir-Spheres 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466856

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Steven G. Meranze, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Steven Meranze, MD, Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00466856     History of Changes
Other Study ID Numbers: VICC GI 0365, VU-VICC-GI-0365
Study First Received: April 25, 2007
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
neoplastic syndrome
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
thyroid gland medullary carcinoma
metastatic pheochromocytoma
recurrent islet cell carcinoma
liver metastases
recurrent pheochromocytoma
gastrinoma
insulinoma
WDHA syndrome
glucagonoma
pancreatic polypeptide tumor
somatostatinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasms
Neuroendocrine Tumors
Pheochromocytoma
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplastic Processes
Neuroectodermal Tumors
Paraganglioma
Pathologic Processes
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014