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

Study Overview

Internal Radiation Therapy in Treating Patients With Liver 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.

Head and Neck Cancer
Islet Cell Tumor
Metastatic Cancer
Pheochromocytoma

DRUG: octreotide acetate
RADIATION: yttrium Y 90 resin microspheres

VICC GI 0365
VU-VICC-GI-0365

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-04-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-05-17
First Submitted that Met QC Criteria 2007-04-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-05-18
First Posted (ESTIMATED) 2007-04-27	Results First Posted N/A	Last Verified 2012-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 RADIATION: yttrium Y 90 resin microspheres radiation

Participant Group/Arm

Intervention/Treatment

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

RADIATION: yttrium Y 90 resin microspheres

radiation

Primary Outcome Measures	Measure Description	Time Frame
Tumor response		at 1 year or until intervening death

Secondary Outcome Measures	Measure Description	Time Frame
Toxicity as measured by CTC v3.0		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	The Carcinoid Symptom Severity Scale is a self-report instrument that addresses the severity and frequency of symptoms and their impact on daily living.	at 1 year or until intervening death
Patient report of Health-related quality of life (HRQOL)	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.	at 1 year or until intervening death

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Steven G. Meranze, MD, Vanderbilt-Ingram Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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