NCT00582608

Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 1 Year – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9 has never been given to a human patient.

Detailed description

To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors. A total of 60 patients will be accrued over a period of 2 years.

Conditions

• CNS Cancer
• Neuroblastoma
• Sarcoma

Interventions

Type	Name	Description
DRUG	131I-8H9	This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m\^2 dose \[intended specific activity of \~20 mCi/mg protein\]
DRUG	8H9	administration of 50mg/1.73m\^2 of unlabeled 8H9.

Timeline

• Start date: 2001-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-12-28
• Last updated: 2017-03-01
• Results posted: 2017-03-01

Locations

1 site across 1 country: United States