Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089427
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2004-08-05
Brief Title:
IL13-PE38QQR Infusion After Tumor Resection Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
Phase I Study of Convection Enhanced Delivery CED of IL13-PE38QQR Infusion After Resection Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2011-04
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:
This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery CED to the area around the tumor site after the tumor is surgically removed resection In addition the patient will receive radiation therapy and may or may not be treated with oral temozolomide
Detailed Description:
This is a Phase I clinical trial of experimental drug IL13-PE38QQR Study Drug in patients with newly diagnosed malignant glioma 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 within 14 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
Following treatment with IL13-PE38QQR all patients will receive standard courses of radiation therapy In addition some patients will receive adjuvant temozolomide with radiation therapy and continue with temozolomide after radiation therapy is completed
Temozolomide is an anti-cancer drug that is approved by the US Food and Drug Administration FDA and sold for the treatment of recurrent GBM
This study will determine the maximum tolerated dose of IL13-PE38QQR when administered by CED after tumor resection and prior to radiation therapy with or without adjuvant temozolomide Patients with newly diagnosed malignant glioma who have had a gross total resection of their tumor and who meet all other specified eligibility criteria may be entered into the study
Patients will be divided into 2 groups
1 Stratum A - will receive treatment with IL13-PE38QQR followed by radiation therapy and
2 Stratum B - will receive treatment with IL13-PE38QQR followed by radiation therapy with adjuvant temozolomide Treatment with temozolomide for Stratum B will continue after radiation therapy is completed
Subgroups cohorts of patients will be treated with up to 3 doses of IL13-PE38QQR Cohorts of 3-6 patients will be treated at each dose level Enrollment into each subsequent cohort will be dependent upon the safety and tolerability of treatment in the previous cohort
All patients will need to have histopathological confirmation of malignant glioma diagnosis from tissue sample obtained at the time of gross total resection within 14 days of stereotactic catheter placement Each patient will have 2-4 standard microinfusion catheters placed and infusion of IL13-PE38QQR will begin within 24 hours of catheter placement The infusion will last for 96 hours Approximately 2 weeks after completion of infusion imaging for radiation therapy planning a physical examination and neurological and laboratory assessments will be performed Patients if stable will then receive standard fractionated external beam radiation therapy with a total dose between 5940-6100 cGy using 180 to 200 cGy per fraction
For those patients assigned to receive temozolomide in combination with radiation therapy the dose of temozolomide will be administered on each day of radiation therapy and will be based on the patients body surface area BSA at a dose of 75 mgm²day After radiation therapy is completed and the follow-up MRI has revealed stable disease or a response patients will continue temozolomide using repeat scheduled dosing at 150 -200 mgm²day for 5 consecutive days per 28 day cycle Treatment cycles will continue for up to 12 cycles
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 within 14 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
Following treatment with IL13-PE38QQR all patients will receive standard courses of radiation therapy In addition some patients will receive adjuvant temozolomide with radiation therapy and continue with temozolomide after radiation therapy is completed
Temozolomide is an anti-cancer drug that is approved by the US Food and Drug Administration FDA and sold for the treatment of recurrent GBM
This study will determine the maximum tolerated dose of IL13-PE38QQR when administered by CED after tumor resection and prior to radiation therapy with or without adjuvant temozolomide Patients with newly diagnosed malignant glioma who have had a gross total resection of their tumor and who meet all other specified eligibility criteria may be entered into the study
Patients will be divided into 2 groups
1 Stratum A - will receive treatment with IL13-PE38QQR followed by radiation therapy and
2 Stratum B - will receive treatment with IL13-PE38QQR followed by radiation therapy with adjuvant temozolomide Treatment with temozolomide for Stratum B will continue after radiation therapy is completed
Subgroups cohorts of patients will be treated with up to 3 doses of IL13-PE38QQR Cohorts of 3-6 patients will be treated at each dose level Enrollment into each subsequent cohort will be dependent upon the safety and tolerability of treatment in the previous cohort
All patients will need to have histopathological confirmation of malignant glioma diagnosis from tissue sample obtained at the time of gross total resection within 14 days of stereotactic catheter placement Each patient will have 2-4 standard microinfusion catheters placed and infusion of IL13-PE38QQR will begin within 24 hours of catheter placement The infusion will last for 96 hours Approximately 2 weeks after completion of infusion imaging for radiation therapy planning a physical examination and neurological and laboratory assessments will be performed Patients if stable will then receive standard fractionated external beam radiation therapy with a total dose between 5940-6100 cGy using 180 to 200 cGy per fraction
For those patients assigned to receive temozolomide in combination with radiation therapy the dose of temozolomide will be administered on each day of radiation therapy and will be based on the patients body surface area BSA at a dose of 75 mgm²day After radiation therapy is completed and the follow-up MRI has revealed stable disease or a response patients will continue temozolomide using repeat scheduled dosing at 150 -200 mgm²day for 5 consecutive days per 28 day cycle Treatment cycles will continue for up to 12 cycles
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