Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064779
Status:
COMPLETED
Last Update Posted:
2011-06-06
First Post:
2003-07-11
Brief Title:
Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients With Recurrent Malignant Glioma
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
Pilot Imaging Study to Assess the Distribution of IL13-PE38QQR Cytotoxin Infusions in Patients With Recurrent Resectable Supratentorial Malignant Glioma
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 experimental anti-cancer drug IL13-PE38QQR which is being developed for the treatment of malignant brain tumors is composed of parts of two proteins the immune system cytokine IL13 and a toxin from the bacterium Pseudomonas aeruginosa The IL13 part of the drug binds to another protein the IL13 receptor when this receptor is displayed on the outside surface of cells Cells with drug bound to the IL13 receptor take up the drug and the toxin part of the drug then kills those cells Since brain tumor cells display the IL13 receptor they are potential targets that may be killed by this drug This is a pilot study to visualize the distribution of IL13-PE38QQR infused into and around brain tumor tissue before and after surgical removal of the tumor in adult patients with recurrent malignant glioma
Stored tumor tissue will be tested for presence of the receptor protein which is required for study entry Eligible patients will then undergo biopsy to confirm the diagnosis of recurrent malignant glioma IL13-PE38QQR will be infused for 96 hours into and around tumor tissue through catheters that have been placed surgically For the first 48 hours the drug will be mixed with a radioactive tracer so that the distribution of the drug can be followed by a type of scanning called SPECT Surgery to remove the tumor will be performed approximately 15 days after the end of the infusion Catheters will again be placed surgically and IL13-PE38QQR will be infused a second time for 96 hours Radioactive tracer will be included in the infusion for the first 48 hours For both infusions SPECT scans will be taken at 6 24 and 48 hours after the start of infusion MRI scans will be taken within 90 minutes of the 24 and 48 hour SPECT scans Patients will be followed closely with further scans and laboratory tests until completion of the study approximately 58 days after completion of the second infusion
Stored tumor tissue will be tested for presence of the receptor protein which is required for study entry Eligible patients will then undergo biopsy to confirm the diagnosis of recurrent malignant glioma IL13-PE38QQR will be infused for 96 hours into and around tumor tissue through catheters that have been placed surgically For the first 48 hours the drug will be mixed with a radioactive tracer so that the distribution of the drug can be followed by a type of scanning called SPECT Surgery to remove the tumor will be performed approximately 15 days after the end of the infusion Catheters will again be placed surgically and IL13-PE38QQR will be infused a second time for 96 hours Radioactive tracer will be included in the infusion for the first 48 hours For both infusions SPECT scans will be taken at 6 24 and 48 hours after the start of infusion MRI scans will be taken within 90 minutes of the 24 and 48 hour SPECT scans Patients will be followed closely with further scans and laboratory tests until completion of the study approximately 58 days after completion of the second infusion
Detailed Description:
OBJECTIVES
Assess the distribution of IL13-PE38QQR following continuous infusion via catheters into recurrent malignant glioma prior to surgical resection and a continuous infusion via catheters into brain tissue adjacent to tumor resection site after surgical resection 123I-HSA tracer will be used as a surrogate for study drug distribution
Determine the toxicities associated with administration of IL13-PE38QQR as described above
Assess the effect on distribution of IL13-PE38QQR of varying the catheter type up to 3 and flow rate per catheter keeping the total flow rates constant for the pre- and post-resection infusions
OUTLINE This is a pilot study to assess the distribution of IL13-PE38QQR delivered by intratumoral infusion prior to surgical resection and by interstitial infusion into tissue surrounding the resection site peritumoral after surgical resection Prior to resection catheters will be placed in the region of the solid contrast-enhancing tumor component The volume of infusion the duration of infusion and the concentration of IL13-PE38QQR in the infusate will be fixed For the post-resection infusion catheters will be placed peritumorally into areas at greatest risk for residual or infiltrating tumor The post-resection volume of infusion the duration of infusion and the concentration of IL13-PE38QQR in the infusate will be fixed For the first 48 hours of each infusion IL13-PE38QQR will be prepared with 123I-HSA tracer as the surrogate for distribution of study drug The type and number of catheters utilized to deliver the pre- and post-surgery infusions will vary To maintain a fixed total volume of infusate over 96 hours the rate of infusion will vary depending upon the number of catheters utilized Up to three different catheter types will be tested However only the same single type of catheter will be utilized for the pre- and post-resection infusions for a given patient
To allow assessment of the distribution of the infused material the first 48 hours of both the pre- and post-resection infusions will utilize 123I-HSA in the infusate For the last 48 hours of both infusions the 123I-HSA will be replaced by non-labeled HSA The distribution of the 123I-HSA tracer will be measured by Single-Photon Emission Computed Tomography SPECT scanning
PROJECTED ACCRUAL Up to 18 patients will be enrolled at a single site
Assess the distribution of IL13-PE38QQR following continuous infusion via catheters into recurrent malignant glioma prior to surgical resection and a continuous infusion via catheters into brain tissue adjacent to tumor resection site after surgical resection 123I-HSA tracer will be used as a surrogate for study drug distribution
Determine the toxicities associated with administration of IL13-PE38QQR as described above
Assess the effect on distribution of IL13-PE38QQR of varying the catheter type up to 3 and flow rate per catheter keeping the total flow rates constant for the pre- and post-resection infusions
OUTLINE This is a pilot study to assess the distribution of IL13-PE38QQR delivered by intratumoral infusion prior to surgical resection and by interstitial infusion into tissue surrounding the resection site peritumoral after surgical resection Prior to resection catheters will be placed in the region of the solid contrast-enhancing tumor component The volume of infusion the duration of infusion and the concentration of IL13-PE38QQR in the infusate will be fixed For the post-resection infusion catheters will be placed peritumorally into areas at greatest risk for residual or infiltrating tumor The post-resection volume of infusion the duration of infusion and the concentration of IL13-PE38QQR in the infusate will be fixed For the first 48 hours of each infusion IL13-PE38QQR will be prepared with 123I-HSA tracer as the surrogate for distribution of study drug The type and number of catheters utilized to deliver the pre- and post-surgery infusions will vary To maintain a fixed total volume of infusate over 96 hours the rate of infusion will vary depending upon the number of catheters utilized Up to three different catheter types will be tested However only the same single type of catheter will be utilized for the pre- and post-resection infusions for a given patient
To allow assessment of the distribution of the infused material the first 48 hours of both the pre- and post-resection infusions will utilize 123I-HSA in the infusate For the last 48 hours of both infusions the 123I-HSA will be replaced by non-labeled HSA The distribution of the 123I-HSA tracer will be measured by Single-Photon Emission Computed Tomography SPECT scanning
PROJECTED ACCRUAL Up to 18 patients will be enrolled at a single site
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