NCT00037869

High Dose I-131 Metaiodobenzylguanidine(MIBG) for Metastatic Neuroendocrine Tumors

High Dose I-131 Metaiodobenzylguanidine (MIBG) Therapy for Metastatic Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if I-131 Metaiodobenzylguanidine (MIBG) can shrink or slow the growth of the tumor(s) in patients with metastatic neuroendocrine tumors. The safety of this treatment will also be studied.

Detailed description

MIBG is used to visualize a group of specific cells in the body. It has been known to deliver the radioactive iodine to the tumor (cancer) cells selectively and result in their destruction. Before treatment starts, patients will be evaluated with a tracer scan, using either I-131 MIBG or I-123 MIBG to locate the tumor site(s). If no MIBG accumulation can be found within tumor sites, the patient will not be able to continue on this study. Patients will also have CT scans and urine and blood tests. Women able to have children will have a pregnancy test. If tumor sites are found and patients are fully eligible, they will receive a therapeutic (treatment) dose of I-131 MIBG by vein over 120 minutes. Some patients may have to receive a lower dose of MIBG. Patients will require hospitalization for treatment and will remain hospitalized for about 3-6 days.

Conditions

• Neuroendocrine Tumors
• Metastases, Neoplasm

Interventions

Type	Name	Description
DRUG	I-131 Metaiodobenzylguanidine

Timeline

• Start date: 2001-11-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2002-05-27
• Last updated: 2018-10-31

Locations

1 site across 1 country: United States