Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003842
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
1999-11-01
Brief Title:
IL-438-37-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma
Sponsor:
Barrett Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of a Recombinant Chimeric Protein Composed of Circularly Permuted IL-4 and a Mutated Form of the Pseudomonas Exotoxin Termed IL-438-37-PE38KDEL IL-4 Toxin for the Treatment of Recurrent Malignant Astrocytoma
Status:
UNKNOWN
Status Verified Date:
1999-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 IL-438-37-PE38KDEL immunotoxin may locate tumor cells and kill them without harming normal cells This may be an effective treatment for recurrent malignant astrocytoma
PURPOSE Phase I trial to study the effectiveness of IL-438-37-PE38KDEL immunotoxin in treating patients who have recurrent malignant astrocytoma
PURPOSE Phase I trial to study the effectiveness of IL-438-37-PE38KDEL immunotoxin in treating patients who have recurrent malignant astrocytoma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of intratumorally infused IL-438-37-PE38KDEL immunotoxin in patients with recurrent malignant astrocytoma II Determine the safety of this regimen in these patients III Determine preliminarily any efficacy of this regimen in these patients
OUTLINE This is a dose escalation multicenter study Patients undergo a stereotactic biopsy under MRCT guidance Catheters are then placed into the tumor under stereotactic guidance The catheter is filled with IL-438-37-PE38KDEL immunotoxin IL-4 toxin with infusion beginning 24 hours after catheter insertion The IL-4 toxin is infused over 4 days The catheter is removed 45 minutes after the infusion is completed and a MR scan is performed Cohorts of 3 patients each receive escalating doses of IL-4 toxin until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding the dose at which 2 of 3 patients experience dose limiting toxicity Patients are followed every 4 weeks for 16 weeks then every 8 weeks for up to 3 years
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study Patients undergo a stereotactic biopsy under MRCT guidance Catheters are then placed into the tumor under stereotactic guidance The catheter is filled with IL-438-37-PE38KDEL immunotoxin IL-4 toxin with infusion beginning 24 hours after catheter insertion The IL-4 toxin is infused over 4 days The catheter is removed 45 minutes after the infusion is completed and a MR scan is performed Cohorts of 3 patients each receive escalating doses of IL-4 toxin until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding the dose at which 2 of 3 patients experience dose limiting toxicity Patients are followed every 4 weeks for 16 weeks then every 8 weeks for up to 3 years
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-V99-1536 | None | None | None |
| UCMC-981061 | None | None | None |
| NBI-3001-9802 | None | None | None |