Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas
|ClinicalTrials.gov Identifier: NCT01317888|
Recruitment Status : Unknown
Verified January 2011 by Drexel University.
Recruitment status was: Active, not recruiting
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
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The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).
|Condition or disease||Intervention/treatment|
|Glioblastoma Multiforme Astrocytoma Anaplastic Foci||Drug: MAB-425 radiolabeled with I-125|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2014|
Experimental: Treated with MAB-425
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
Drug: MAB-425 radiolabeled with I-125
MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.
Primary Outcome Measures :
- Prevention of disease progression [ Time Frame: 3 months after first course with follow-up ]For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline
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