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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582608 |
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.
Condition | Intervention |
CNS Cancer Neuroblastoma Sarcoma |
Drug: MAB 131-I LABELED 8H9 |
MedlinePlus related topics: | Cancer Neuroblastoma Soft Tissue Sarcoma |
Drug Information available for: | Iodine Cadexomer iodine Sodium iodide I 131 |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9 |
Estimated Enrollment: | 60 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: MAB 131-I LABELED 8H9
This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
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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.
Ages Eligible for Study: | 1 Year to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shakeel Modak, MD | modaks@mskcc.org |
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10065 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Shakeel Modak, MD | Memorial Sloan-Kettering Cancer Center |
Related Info 
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Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Shakeel Modak, MD ) |
Study ID Numbers: | 00-066 |
First Received: | December 21, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00582608 |
Health Authority: | United States: Food and Drug Administration |
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