A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas
data from the wistar institute indicated that this anti-body labeled with iodine-125 would localized in the tumor cells of high grade gliomas of the brain. the project combines surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II trial in this disease entity.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study o the Adjuvant Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFR-425) Monoclonal Antibody Radiolabeled With I-125 for High Grade Gliomas|
- survival [ Time Frame: more than a year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 1985|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
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.Drug: MAb-425
All patient receive MAb-425 along with Iodine-125 as an injection for a total of three treatments.Each treatment is separated by one week.