Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378235
Status:
WITHDRAWN
Last Update Posted:
2014-11-13
First Post:
2006-09-18
Brief Title:
Phase III Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
Phase III Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma
Status:
WITHDRAWN
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There was a change of sponsor The new sponsor company did not wish to conduct the study after all
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IL13-PE38QQR is an oncology drug product consisting of IL13 interleukin-13 and PE38QQR a bacteria toxin IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13-receptor positive tumor cell lines indicating that it may show a therapeutic benefit In reciprocal competition experiments the interaction between IL13-PE38QQR and the IL13 receptors was shown to be highly specific for human glioma cells
Detailed Description:
PHASE I OBJECTIVES
I To describe toxicities and estimate the maximum safe flow rate and maximum tolerated infusion concentration of IL13-PE38QQR delivered after surgical resection by peritumoral infusion via 2 to 4 catheters positioned in the brain adjacent to the resection cavity from the start of infusion through the DLT observation period
II To determine the IL13 receptor alpha-2 chain expression status and distribution in pediatric recurrent or progressive malignant gliomas
III To describe the overall safety and tolerability of IL13PE38QQR infusion from the start of infusion through disease progression or initiation of alternative treatment
PHASE II OBJECTIVES
I To estimate the survival distribution post initial progression at the maximum safe total flow rate and MTiC established in phase I
II To estimate the progression-free survival distribution for patients post-initial progression or recurrence at the maximum safe total flow rate and MTiC established in phase I
III To determine the serum levels of IL13-PE38QQR and distribution in pediatric recurrent or progressive malignant gliomas
IV To describe the overall safety and tolerability of IL13-PE38QQR infusion from the start of infusion through disease progression or initiation of alternative treatment
PROTOCOL OUTLINE At study entry all patients will be registered prior to planned gross total resection 95 resection of the solid contrast enhancing tumor component On the day of catheter placement CP 2-7 days after resection if the patient is neurologically stable 2-4 catheters will be stereotactically placed On day 1 after catheter placement infusion of IL3-PE38QQR will begin if the patient is neurologically stable and will continue for 96 hours In Phase I the total flow rate and the concentration of IL3-PE38QQR will be determined by the dose escalation plan In the Phase II evaluations of safety and efficacy patients will be treated at the flow rate and concentration identified in Phase I
PROJECTED ACCRUAL Approximately 24 patients will participate in the Phase I portion of the study During the Phase I portion the rate-limiting factor is the time the study must be closed during the toxicity assessment period Although it is estimated that 15 patients per month will enroll in the Phase I portion the observed rate may be lower due to temporary suspensions in accrual It is not possible to estimate the time required to complete the Phase I portion of the trial It is estimated that approximately 26 patients will contribute to the Phase II portion Using the same rough estimate of accrual the Phase II portion may last about 3 years
I To describe toxicities and estimate the maximum safe flow rate and maximum tolerated infusion concentration of IL13-PE38QQR delivered after surgical resection by peritumoral infusion via 2 to 4 catheters positioned in the brain adjacent to the resection cavity from the start of infusion through the DLT observation period
II To determine the IL13 receptor alpha-2 chain expression status and distribution in pediatric recurrent or progressive malignant gliomas
III To describe the overall safety and tolerability of IL13PE38QQR infusion from the start of infusion through disease progression or initiation of alternative treatment
PHASE II OBJECTIVES
I To estimate the survival distribution post initial progression at the maximum safe total flow rate and MTiC established in phase I
II To estimate the progression-free survival distribution for patients post-initial progression or recurrence at the maximum safe total flow rate and MTiC established in phase I
III To determine the serum levels of IL13-PE38QQR and distribution in pediatric recurrent or progressive malignant gliomas
IV To describe the overall safety and tolerability of IL13-PE38QQR infusion from the start of infusion through disease progression or initiation of alternative treatment
PROTOCOL OUTLINE At study entry all patients will be registered prior to planned gross total resection 95 resection of the solid contrast enhancing tumor component On the day of catheter placement CP 2-7 days after resection if the patient is neurologically stable 2-4 catheters will be stereotactically placed On day 1 after catheter placement infusion of IL3-PE38QQR will begin if the patient is neurologically stable and will continue for 96 hours In Phase I the total flow rate and the concentration of IL3-PE38QQR will be determined by the dose escalation plan In the Phase II evaluations of safety and efficacy patients will be treated at the flow rate and concentration identified in Phase I
PROJECTED ACCRUAL Approximately 24 patients will participate in the Phase I portion of the study During the Phase I portion the rate-limiting factor is the time the study must be closed during the toxicity assessment period Although it is estimated that 15 patients per month will enroll in the Phase I portion the observed rate may be lower due to temporary suspensions in accrual It is not possible to estimate the time required to complete the Phase I portion of the trial It is estimated that approximately 26 patients will contribute to the Phase II portion Using the same rough estimate of accrual the Phase II portion may last about 3 years
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 Protocol No PBTC-011 | None | None | None |