Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006268
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2000-09-11
Brief Title:
Immunotoxin Therapy in Treating Patients With Malignant Glioma
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma Phase III Study
Status:
COMPLETED
Status Verified Date:
2005-03
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 This may be an effective treatment for malignant glioma
PURPOSE Phase III trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma
PURPOSE Phase III trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma
Detailed Description:
OBJECTIVES
Determine the toxic effects and maximum tolerated dose MTD of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma
Determine the response rate duration of response time to response overall survival and time to progression in patients treated with this regimen
Determine the toxic effects of this drug at the MTD in these patients
OUTLINE This is a dose-escalation multicenter study
Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0 Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1 Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity Additional patients are treated at the MTD
Patients are followed every 8 weeks
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for phase I of the study within 6 months and a total of 12-35 patients will be accrued for phase II of the study within 10-12 months
Determine the toxic effects and maximum tolerated dose MTD of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma
Determine the response rate duration of response time to response overall survival and time to progression in patients treated with this regimen
Determine the toxic effects of this drug at the MTD in these patients
OUTLINE This is a dose-escalation multicenter study
Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0 Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1 Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity Additional patients are treated at the MTD
Patients are followed every 8 weeks
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for phase I of the study within 6 months and a total of 12-35 patients will be accrued for phase II of the study within 10-12 months
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 |
|---|---|---|---|
| NEOPHARM-IL13PEI-001-R03 | None | None | None |
| NABTT-9903 | None | None | None |
| JHOC-NABTT-9903 | None | None | None |
| NEOPHARM-TS-G1-TI4 | None | None | None |