Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024570
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2001-09-20
Brief Title:
Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma Phase III Study
Status:
COMPLETED
Status Verified Date:
2014-11
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:
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
IL13-PE38QQR will be infused in two courses of 96 hours each eight weeks apart directly into the malignant brain tumors of patients to determine the dose of drug these patients can tolerate After that the selected dose will be studied to give an estimate of the response rate response duration time to response and survival after infusing that dose of IL13-PE38QQR into the recurrent malignant glioma
IL13-PE38QQR will be infused in two courses of 96 hours each eight weeks apart directly into the malignant brain tumors of patients to determine the dose of drug these patients can tolerate After that the selected dose will be studied to give an estimate of the response rate response duration time to response and survival after infusing that dose of IL13-PE38QQR into the recurrent malignant glioma
Detailed Description:
OBJECTIVES
I Determine the toxicities and maximum tolerated dose of IL13-PE38QQR delivered by continuous infusion into malignant glioma over 96 hours in two courses eight weeks apart
II Estimate the response rate response duration time to response and survival after interstitial infusion of IL13-PE38QQR into recurrent malignant glioma
III Describe the toxicities of interstitial infusion of IL13-PE38QQR at the selected dose
PROTOCOL OUTLINE Patients are expected to receive two IL13-PE38QQR infusions at 8-week intervals For each course drug will be infused through each of two catheters infusion rate will be held constant during a 96-hour infusion
In Phase I the dose of IL13-PE38QQR will be increased by increasing the IL13-PE38QQR concentration in stepwise fashion while holding infusion volume and duration constant Three patients will be treated at each dose level until the maximum tolerated dose MTD is reached and an additional three patients are treated at that level In Phase II patients will be treated at the selected MTD
PROJECTED ACCRUAL In Phase I up to 30 patients will be treated In Phase II up to 35 patients will be treated
I Determine the toxicities and maximum tolerated dose of IL13-PE38QQR delivered by continuous infusion into malignant glioma over 96 hours in two courses eight weeks apart
II Estimate the response rate response duration time to response and survival after interstitial infusion of IL13-PE38QQR into recurrent malignant glioma
III Describe the toxicities of interstitial infusion of IL13-PE38QQR at the selected dose
PROTOCOL OUTLINE Patients are expected to receive two IL13-PE38QQR infusions at 8-week intervals For each course drug will be infused through each of two catheters infusion rate will be held constant during a 96-hour infusion
In Phase I the dose of IL13-PE38QQR will be increased by increasing the IL13-PE38QQR concentration in stepwise fashion while holding infusion volume and duration constant Three patients will be treated at each dose level until the maximum tolerated dose MTD is reached and an additional three patients are treated at that level In Phase II patients will be treated at the selected MTD
PROJECTED ACCRUAL In Phase I up to 30 patients will be treated In Phase II up to 35 patients will be treated
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 |
|---|---|---|---|
| JHU-NABTT-9903 | None | None | None |
| NCI-NABTT-9903 | None | None | None |