Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00582608|
Recruitment Status : Terminated (Lack of accrual)
First Posted : December 28, 2007
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|CNS Cancer Neuroblastoma Sarcoma||Drug: 131I-8H9 Drug: 8H9||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Experimental: 131I-8H9 and 8H9
This is an open-label single arm study of 131 I-8H9. injected intravenously at 10mCi/1.73m^2 dose [intended specific activity of `20mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled -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]
administration of 50mg/1.73m^2 of unlabeled 8H9.
- Safety and Toxicity is Measured by the Total Number of Participants Affected [ Time Frame: 2 years ]Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582608
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Shakeel Modak, MD||Memorial Sloan Kettering Cancer Center|