Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00128635
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in patients with progressive or recurrent glioblastoma multiforme.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States