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

NCT ID: NCT00466856

Last Updated: 2012-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2007-10-31

Brief Summary

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.

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.

Conditions

Head and Neck Cancer; Islet Cell Tumor; Metastatic Cancer; Pheochromocytoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sir-Spheres

Group Type: EXPERIMENTAL

octreotide acetate

Intervention Type: DRUG

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

yttrium Y 90 resin microspheres

Intervention Type: RADIATION

radiation

Interventions

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

Intervention Type: DRUG

yttrium Y 90 resin microspheres

radiation

Intervention Type: RADIATION

Other Intervention Names

octreotide; octreotide

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Steven Meranze, MD

Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven G. Meranze, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

VU-VICC-GI-0365

Identifier Type: -

Identifier Source: secondary_id

VICC GI 0365

Identifier Type: -

Identifier Source: org_study_id