Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-29 @ 9:50 PM
Study NCT ID:
NCT00128635
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2005-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NABTT-0404 | None | None | View |