An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131 I-chTNT-1/B MAb (COTARA(TM)) For the Treatment of Glioblastoma Multiforme (GBM) at 1st or 2nd Relapse
- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in
patients with progressive or recurrent glioblastoma multiforme.
- Determine the biodistribution and radiation dosimetry of this drug in these patients.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the overall survival, median time of survival, and 6-month survival of
patients treated with this drug.
OUTLINE: This is an open-label, multicenter, dose-escalation study of therapeutic doses of
iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B).
The first 12 patients accrued to the study undergo stereotactic placement of 2 catheters
within the contrast-enhancing tumor on day 0. These patients then receive an imaging dose of
^131I MOAB TNT-1/B interstitially over approximately 25 hours on day 1 followed by
dosimetry, biodistribution evaluations, and whole body imaging over an 8-10 day period.
Beginning at least 2 weeks, but no more than 4 weeks later, all patients undergo catheter
placement as above. One day later, patients receive a therapeutic dose of ^131I MOAB TNT-1/B
interstitially over approximately 25 hours.
Cohorts of 3-6 patients receive escalating therapeutic doses of ^131I MOAB TNT-1/B until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients
are treated at the MTD.
After completion of study treatment, patients are followed weekly for 3 weeks, at 6 weeks,
at 4, 8, and 12 weeks (for the first 12 patients accrued to the study), every 4 weeks until
disease progression, and then every 8 weeks thereafter.
PROJECTED ACCRUAL: Approximately 22 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks
Robert A. Lustig, MD
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham||Birmingham, Alabama 35294|