Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for glioblastoma multiforme.
PURPOSE: This phase I trial is studying the side effects and best dose of ^131I MOAB TNT-1/B in treating patients with progressive or recurrent glioblastoma multiforme.
|Brain and Central Nervous System Tumors||Radiation: iodine I 131 monoclonal antibody TNT-1/B||Phase 1|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks
- Biodistribution and radiation dosimetry by blood, urine, and whole body scans daily for 10 days
- Toxicity by CTCAE v3.0 weekly for 12 weeks then every 8 weeks
- Overall survival, median time of survival, and percent alive at 6 months
|Study Start Date:||October 2005|
|Study Completion Date:||October 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128635
|United States, Alabama|
|Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Robert A. Lustig, MD||Abramson Cancer Center of the University of Pennsylvania|
|OverallOfficial:||Kevin Judy, MD||Abramson Cancer Center of the University of Pennsylvania|