Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128635
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2005-08-08
Brief Title:
Iodine I 131 Monoclonal Antibody TNT-1B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
An Open-Label Dose Confirmation and Dosimetry Study of Interstitial 131 I-chTNT-1B MAb COTARATM 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-1B 131I MOAB TNT-1B 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-1B 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-1B 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-1B 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-1B 131I MOAB TNT-1B
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-1B 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-1B interstitially over approximately 25 hours
Cohorts of 3-6 patients receive escalating therapeutic doses of 131I MOAB TNT-1B 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-1B 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-1B 131I MOAB TNT-1B
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-1B 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-1B interstitially over approximately 25 hours
Cohorts of 3-6 patients receive escalating therapeutic doses of 131I MOAB TNT-1B 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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NABTT-0404 | None | None | None |