NCT00466856

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-12-01
• Primary completion: 2006-10-01
• Completion: 2007-10-01
• First posted: 2007-04-27
• Last updated: 2012-05-18

Locations

1 site across 1 country: United States