Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-28 @ 6:19 AM
Study NCT ID:
NCT00378235
Status:
WITHDRAWN
Last Update Posted:
2014-11-13
First Post:
2006-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma
Sponsor:
INSYS Therapeutics Inc
Organization:
Study Overview
Official Title:
Phase I/II 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WITHDRAWN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 1.5 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 1.5 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:
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 |
|---|---|---|---|---|
| NCI Protocol No.: PBTC-011 | None | None | View |