Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse
To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B
MAb given as a single interstitial infusion in patients with glioblastoma multiforme at
first relapse.
To estimate overall survival, progression free survival and proportion of patients alive at
six months after treatment.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To confirm the safety and tolerability of the maximum tolerated dose
Unknown
Yes
Deepak K Gupta, MBBS,MS,MCh
Principal Investigator
All India Institute of Medical Sciences, New Delhi
India: Drugs Controller General of India
PPHM 0503
NCT00677716
July 2007
November 2011
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Barrow Neurological Institute | Phoenix, Arizona 85013 |
University of Pennsylvania, Department of Neurosurgery | Philadelphia, Pennsylvania 19104 |