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

NCT00582608 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-03-01

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Shakeel Modak, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00582608 on ClinicalTrials.gov