Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036972
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2002-05-13
Brief Title:
Immunotoxin Therapy Before and After Surgery in Treating Patients With Recurrent Malignant Glioma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study to Assess the Histologic Effect and Safety of Pre-Operative and Post-Operative Infusions of IL13-PE38QQR Cytotoxin in Patients With Recurrent Resectable Supratentorial Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2009-12
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:
RATIONALE Immunotoxins can locate tumor cells and kill them without harming normal cells Immunotoxin therapy may be effective in treating malignant glioma
PURPOSE Phase I trial to study the effectiveness of immunotoxin therapy before and after surgery in treating patients who have recurrent malignant glioma
PURPOSE Phase I trial to study the effectiveness of immunotoxin therapy before and after surgery in treating patients who have recurrent malignant glioma
Detailed Description:
OBJECTIVES
Determine the concentration of interleukin-13 PE38QQR immunotoxin that produces histologic evidence of toxicity to tumor and the corresponding toxic effects of this drug when administered via continuous intratumoral infusion prior to second resection in patients with recurrent resectable supratentorial malignant glioma
Determine the toxic effects of this drug when administered via continuous peritumoral infusion at concentrations determined in objective I after second resection in these patients
Determine any toxic effects of increasing the duration of continuous peritumoral infusion of this drug at concentrations determined in objective II after second resection in these patients
Determine the time to progression and survival of patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Pre-resection therapy initial cohorts of patients only Patients undergo stereotactic biopsy of brain tumor followed by stereotactic placement of 1 intratumoral catheter on day 1 Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin via continuous intratumoral infusion over 48 hours on days 2 and 3
Cohorts of 3-6 patients receive escalating doses of pre-resection interleukin-13 PE38QQR immunotoxin until the histologically effective concentration HEC is reached or maximum tolerated dose MTD is determined The HEC is defined by pathologic observations The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity After the HEC is reached or MTD is determined up to 6 additional patients are enrolled at selected dose levels to study safety and tolerability Subsequent cohorts of patients are not treated with a pre-resection infusion
Resection all patients Patients undergo maximal resection en bloc if feasible followed by placement of 2-3 peritumoral catheters 4 days after completion of pre-resection infusion for the initial cohorts of patients and at study entry for subsequent cohorts of patients
Post-resection therapy all patients Beginning on the second day after resection patients receive interleukin-13 PE38QQR immunotoxin via continuous peritumoral infusion over 96 hours
Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the previously-defined HEC is reached or MTD is determined whichever occurs first If dose-escalation is stopped after HEC is reached then three additional cohorts of patients receive escalating durations 5 6 or 7 days of post-resection infusion If dose escalation is stopped after the MTD is determined then the duration of post-resection infusion is not escalated
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study
Determine the concentration of interleukin-13 PE38QQR immunotoxin that produces histologic evidence of toxicity to tumor and the corresponding toxic effects of this drug when administered via continuous intratumoral infusion prior to second resection in patients with recurrent resectable supratentorial malignant glioma
Determine the toxic effects of this drug when administered via continuous peritumoral infusion at concentrations determined in objective I after second resection in these patients
Determine any toxic effects of increasing the duration of continuous peritumoral infusion of this drug at concentrations determined in objective II after second resection in these patients
Determine the time to progression and survival of patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Pre-resection therapy initial cohorts of patients only Patients undergo stereotactic biopsy of brain tumor followed by stereotactic placement of 1 intratumoral catheter on day 1 Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin via continuous intratumoral infusion over 48 hours on days 2 and 3
Cohorts of 3-6 patients receive escalating doses of pre-resection interleukin-13 PE38QQR immunotoxin until the histologically effective concentration HEC is reached or maximum tolerated dose MTD is determined The HEC is defined by pathologic observations The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity After the HEC is reached or MTD is determined up to 6 additional patients are enrolled at selected dose levels to study safety and tolerability Subsequent cohorts of patients are not treated with a pre-resection infusion
Resection all patients Patients undergo maximal resection en bloc if feasible followed by placement of 2-3 peritumoral catheters 4 days after completion of pre-resection infusion for the initial cohorts of patients and at study entry for subsequent cohorts of patients
Post-resection therapy all patients Beginning on the second day after resection patients receive interleukin-13 PE38QQR immunotoxin via continuous peritumoral infusion over 96 hours
Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the previously-defined HEC is reached or MTD is determined whichever occurs first If dose-escalation is stopped after HEC is reached then three additional cohorts of patients receive escalating durations 5 6 or 7 days of post-resection infusion If dose escalation is stopped after the MTD is determined then the duration of post-resection infusion is not escalated
Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-01141 | None | None | None |
| CDR0000069345 | REGISTRY | None | None |
| NCI-G02-2066 | Registry Identifier | PDQ Physician Data Query | None |