Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002752
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
1999-11-01
Brief Title:
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS
Status:
COMPLETED
Status Verified Date:
2013-02
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 Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer
PURPOSE Phase III trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer
Detailed Description:
OBJECTIVES
Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas
Determine the objective therapeutic response of these patients treated with this regimen
OUTLINE This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 MOAB 81C6 Patients are stratified by prior external beam radiotherapy yes vs no
Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly
Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 2 years every 2 months for 2 years and then every 3 months thereafter
PROJECTED ACCRUAL A total of 3-6 patients per cohort will be accrued for this study
Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas
Determine the objective therapeutic response of these patients treated with this regimen
OUTLINE This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 MOAB 81C6 Patients are stratified by prior external beam radiotherapy yes vs no
Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly
Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 2 years every 2 months for 2 years and then every 3 months thereafter
PROJECTED ACCRUAL A total of 3-6 patients per cohort 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 |
|---|---|---|---|
| CDR0000064688 | OTHER | NCI | None |
| DUMC-2426-01-2R8 | OTHER | None | None |
| DUMC-000223-00-2R7 | OTHER | None | None |
| DUMC-0328-99-2R6 | OTHER | None | None |
| DUMC-221-96-2R3 | OTHER | None | None |
| DUMC-307-97-2R4 | None | None | None |
| DUMC-307-98-2R5 | None | None | None |
| NCI-H96-0009 | None | None | None |