Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053040
Status:
WITHDRAWN
Last Update Posted:
2010-09-24
First Post:
2003-01-27
Brief Title:
Immunotoxin Therapy in Treating Children With Recurrent Malignant Gliomas
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
Phase III Trial Of Intracerebral IL13-PE38QQR Infusions In Pediatric Patients With Recurrent Malignant Glioma
Status:
WITHDRAWN
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawal of pharmaceutical company support for the investigational drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Immunotoxins can locate tumor cells and kill them without harming normal cells
PURPOSE This phase III trial is studying the side effects and best dose of immunotoxin therapy and to see how well it works in treating children undergoing surgery for recurrent or progressive malignant glioma
PURPOSE This phase III trial is studying the side effects and best dose of immunotoxin therapy and to see how well it works in treating children undergoing surgery for recurrent or progressive malignant glioma
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity of peritumoral IL13-PE38QQR after surgical resection in pediatric patients with recurrent malignant gliomas Phase I
Determine the maximum tolerated flow rate and maximum tolerated infusion concentration MTiC of this drug in these patients Phase I
Estimate the rate of survival after initial progression in patients treated at the maximum safe flow rate and MTiC with this drug Phase II
Secondary
Describe the overall safety and tolerability of this regimen in these patients from the start of infusion through disease progression or initiation of alternative treatment
Determine the IL13 receptor α2 chain expression status and distribution in pediatric recurrent or progressive malignant gliomas
Estimate the progression-free survival of patients treated with this drug Phase II
OUTLINE This is a multicenter dose-escalation study
Phase I Patients undergo surgical resection of the tumor Within 2-7 days later patients undergo placement of 2-4 peritumoral catheters One to 2 days later patients receive peritumoral IL13-PE38QQR continuously over 96 hours Catheters are removed after completion of the infusion
Cohorts of 3 patients receive IL13-PE38QQR at escalating flow rates and a fixed concentration until the maximum safe flow rate is determined The maximum safe flow rate is defined as the rate prior to the one at which 2 of 3 or more patients experience dose-limiting toxicity
Following determination of the maximum safe flow rate cohorts of 2-3 patients receive IL13-PE38QQR at escalating concentrations at the maximum safe flow rate until the maximum tolerated infusion concentration MTiC is determined The MTiC is defined as the concentration prior to the one at which 2 of 3 or more patients experience dose-limiting toxicity
Phase II Patients receive IL13-PE38QQR as above at the maximum safe flow rate and MTiC determined in the phase I of the study
Patients are followed at week 18 after catheter placement and then every 8 weeks thereafter until death disease progression or completion of six months phase I or 12 months phase II of follow-up after the end of IL13-PE38QQR infusion Phase II patients who complete one year of follow-up without disease progression are followed every 12 weeks thereafter until death
PROJECTED ACCRUAL Approximately 2-50 patients 2-24 for phase I and approximately 26 for phase II will be accrued for this study
Primary
Determine the toxicity of peritumoral IL13-PE38QQR after surgical resection in pediatric patients with recurrent malignant gliomas Phase I
Determine the maximum tolerated flow rate and maximum tolerated infusion concentration MTiC of this drug in these patients Phase I
Estimate the rate of survival after initial progression in patients treated at the maximum safe flow rate and MTiC with this drug Phase II
Secondary
Describe the overall safety and tolerability of this regimen in these patients from the start of infusion through disease progression or initiation of alternative treatment
Determine the IL13 receptor α2 chain expression status and distribution in pediatric recurrent or progressive malignant gliomas
Estimate the progression-free survival of patients treated with this drug Phase II
OUTLINE This is a multicenter dose-escalation study
Phase I Patients undergo surgical resection of the tumor Within 2-7 days later patients undergo placement of 2-4 peritumoral catheters One to 2 days later patients receive peritumoral IL13-PE38QQR continuously over 96 hours Catheters are removed after completion of the infusion
Cohorts of 3 patients receive IL13-PE38QQR at escalating flow rates and a fixed concentration until the maximum safe flow rate is determined The maximum safe flow rate is defined as the rate prior to the one at which 2 of 3 or more patients experience dose-limiting toxicity
Following determination of the maximum safe flow rate cohorts of 2-3 patients receive IL13-PE38QQR at escalating concentrations at the maximum safe flow rate until the maximum tolerated infusion concentration MTiC is determined The MTiC is defined as the concentration prior to the one at which 2 of 3 or more patients experience dose-limiting toxicity
Phase II Patients receive IL13-PE38QQR as above at the maximum safe flow rate and MTiC determined in the phase I of the study
Patients are followed at week 18 after catheter placement and then every 8 weeks thereafter until death disease progression or completion of six months phase I or 12 months phase II of follow-up after the end of IL13-PE38QQR infusion Phase II patients who complete one year of follow-up without disease progression are followed every 12 weeks thereafter until death
PROJECTED ACCRUAL Approximately 2-50 patients 2-24 for phase I and approximately 26 for phase II will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5930 | OTHER | NCI | None |
| PBTC-011C | OTHER | None | None |
| NEOPHARM-IL13PEI-151 | OTHER | None | None |