Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076986
Status:
COMPLETED
Last Update Posted:
2011-06-06
First Post:
2004-02-06
Brief Title:
The PRECISE Trial Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL Wafer With Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the PRECISE trial is to determine whether overall survival duration safety and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme
Detailed Description:
PRECISE is a Phase III clinical trial of experimental drug IL13-PE38QQR Study Drug IL13-PE38QQR is a tumor-targeting agent administered by a continuous infusion directly into the brain around the cavity where the tumor has been removed Through previous research this Study Drug has shown potential to control some of the recurrent malignant gliomas such as glioblastoma multiforme GBM anaplastic astrocytoma and malignant mixed oligoastrocytoma
The Study Drug is made by combining a human protein IL13 with a portion of a bacterial toxin protein Pseudomonas Exotoxin PE The IL13 portion binds to receptors on the tumor like a key to a lock allowing the PE portion to enter and kill those cells Since tumor cells preferentially bind the drug normal healthy brain cells are much less likely to be damaged by the drug The Study Drug is delivered through tubing or catheters placed directly into the area surrounding the resection cavity These catheters will be surgically placed from 2-7 days after the tumor has been removed A pump is then used to slowly push the drug solution through the catheters using convection-enhanced delivery CED over a period of 4 days
The GLIADEL Wafer is an anti-cancer drug that is approved by the US Food and Drug Administration FDA and sold for the treatment of recurrent or newly diagnosed GBM Patients receiving GLIADEL will have wafers placed at the time of surgery to remove tumor
Eligible patients enrolled in the PRECISE trial will be randomly assigned to receive either IL13-PE38QQR or GLIADEL Wafer Patients will have a 2 out of 3 chance to receive IL13-PE38QQR and 1 out of 3 chance to receive GLIADEL Wafer
The Study Drug is made by combining a human protein IL13 with a portion of a bacterial toxin protein Pseudomonas Exotoxin PE The IL13 portion binds to receptors on the tumor like a key to a lock allowing the PE portion to enter and kill those cells Since tumor cells preferentially bind the drug normal healthy brain cells are much less likely to be damaged by the drug The Study Drug is delivered through tubing or catheters placed directly into the area surrounding the resection cavity These catheters will be surgically placed from 2-7 days after the tumor has been removed A pump is then used to slowly push the drug solution through the catheters using convection-enhanced delivery CED over a period of 4 days
The GLIADEL Wafer is an anti-cancer drug that is approved by the US Food and Drug Administration FDA and sold for the treatment of recurrent or newly diagnosed GBM Patients receiving GLIADEL will have wafers placed at the time of surgery to remove tumor
Eligible patients enrolled in the PRECISE trial will be randomly assigned to receive either IL13-PE38QQR or GLIADEL Wafer Patients will have a 2 out of 3 chance to receive IL13-PE38QQR and 1 out of 3 chance to receive GLIADEL Wafer
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 |
|---|---|---|---|
| PRECISE Trial | None | None | None |