Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074334
Status:
TERMINATED
Last Update Posted:
2009-10-21
First Post:
2003-12-10
Brief Title:
TP-38 Toxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
A Phase III Study Of A Recombinant Chimeric Protein Composed Of Transforming Growth Factor TGF-a And A Mutated Pseudomonas Exotoxin Termed PE38 TP-38 In Pediatric Patients With Recurrent Or Progressive Supratentorial High Grade Gliomas
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug company withdrawal of support for investigational agent in this indication
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE The TP-38 toxin can locate tumor cells and kill them without harming normal cells Giving TP-38 toxin directly into the tumor may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of TP-38 toxin administered directly into the brain and to see how well it works in treating young patients with recurrent or progressive supratentorial high-grade glioma
PURPOSE This phase III trial is studying the side effects and best dose of TP-38 toxin administered directly into the brain and to see how well it works in treating young patients with recurrent or progressive supratentorial high-grade glioma
Detailed Description:
OBJECTIVES
Primary
Phase I
Determine the maximum safe volume rate and maximum tolerated infusion concentration of TGFa-PE38 toxin TP-38 infused through 2 or 3 catheters in pediatric patients with recurrent or progressive supratentorial high-grade glioma
Describe the toxic effects of this drug in these patients
Phase II
Estimate the efficacy of this drug in terms of post-infusion survival in these patients
Secondary
Phase I and II
Determine the prevalence of epidermal growth factor receptor EGFR expression and phosphorylation activity in patients treated with this drug
Correlate EGFR expression with qualitative measures eg histology grade and other tumor characteristics and tumor response survival and progression-free survival in patients treated with this drug
Phase II Only
Estimate the objective response rate in patients treated with this drug
Estimate the progression-free survival of patients treated with this drug
OUTLINE This is a dose-escalation multicenter study Patients in the phase I portion of the study are stratified according to the number of successfully placed catheters 3 catheters vs 2 catheters Patients in the phase II portion of the study are stratified according to time of recurrence of high-grade glioma first vs second or greater and by surgery extent surgical resection vs stereotactic biopsy for those with first recurrence only
Phase I Patients undergo stereotactic biopsy or resection of the tumor followed by intratumoral or tumor bed catheter placement for treatment infusion Within 12-48 hours after intratumoral or tumor bed catheter placement patients receive TGFa-PE38 toxin TP-38 intratumorally through 2 or 3 catheters over 33 to 124 hours Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each stratum receive escalating volumes until the maximum safe volume MSV is determined Cohorts of 3-6 patients in each stratum receive escalating concentrations at the MSV until the maximum tolerated infusion concentration MTIC is determined The MSV and MTIC are defined as the volume and concentration preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MSV and MTIC
Phase I patients are followed post catheter placement daily during TP-38 infusion at 30 days and then every 2 months for 1 year Phase II patients will be followed for an additional year
PROJECTED ACCRUAL A total of 6-105 patients 6-60 for phase I and 45 for phase II will be accrued for this study
Primary
Phase I
Determine the maximum safe volume rate and maximum tolerated infusion concentration of TGFa-PE38 toxin TP-38 infused through 2 or 3 catheters in pediatric patients with recurrent or progressive supratentorial high-grade glioma
Describe the toxic effects of this drug in these patients
Phase II
Estimate the efficacy of this drug in terms of post-infusion survival in these patients
Secondary
Phase I and II
Determine the prevalence of epidermal growth factor receptor EGFR expression and phosphorylation activity in patients treated with this drug
Correlate EGFR expression with qualitative measures eg histology grade and other tumor characteristics and tumor response survival and progression-free survival in patients treated with this drug
Phase II Only
Estimate the objective response rate in patients treated with this drug
Estimate the progression-free survival of patients treated with this drug
OUTLINE This is a dose-escalation multicenter study Patients in the phase I portion of the study are stratified according to the number of successfully placed catheters 3 catheters vs 2 catheters Patients in the phase II portion of the study are stratified according to time of recurrence of high-grade glioma first vs second or greater and by surgery extent surgical resection vs stereotactic biopsy for those with first recurrence only
Phase I Patients undergo stereotactic biopsy or resection of the tumor followed by intratumoral or tumor bed catheter placement for treatment infusion Within 12-48 hours after intratumoral or tumor bed catheter placement patients receive TGFa-PE38 toxin TP-38 intratumorally through 2 or 3 catheters over 33 to 124 hours Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each stratum receive escalating volumes until the maximum safe volume MSV is determined Cohorts of 3-6 patients in each stratum receive escalating concentrations at the MSV until the maximum tolerated infusion concentration MTIC is determined The MSV and MTIC are defined as the volume and concentration preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive treatment as in phase I at the MSV and MTIC
Phase I patients are followed post catheter placement daily during TP-38 infusion at 30 days and then every 2 months for 1 year Phase II patients will be followed for an additional year
PROJECTED ACCRUAL A total of 6-105 patients 6-60 for phase I and 45 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 |
|---|---|---|---|
| PBTC-013 | None | None | None |