Ignite Creation Date:
2024-05-05 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002753
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Recurrent Gliomas
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
PROTOCOL FOR A PHASE I STUDY OF INTRACYSTIC ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 IN THE TREATMENT OF PATIENTS WITH RECURRENT CYSTIC GLIOMAS
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas
PURPOSE Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas
Detailed Description:
OBJECTIVES I Assess the toxic effects of intracystic administration of iodine-131-labeled anti-tenascin monoclonal antibody 81C6 II Identify any objective therapeutic responses to this treatment in patients with recurrent cystic anaplastic gliomas
OUTLINE Radioimmunotherapy Iodine-131-Labeled Anti-Tenascin Monoclonal Antibody 81C6 131I-81C6
PROJECTED ACCRUAL Three to six patients will be entered at each dose studied
OUTLINE Radioimmunotherapy Iodine-131-Labeled Anti-Tenascin Monoclonal Antibody 81C6 131I-81C6
PROJECTED ACCRUAL Three to six patients will be entered at each dose studied
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-H96-0008 | None | None | None |
| DUMC-1775-95-12R4 | None | None | None |
| DUMC-1752-96-12R5 | None | None | None |
| DUMC-1965-98-12R7 | None | None | None |
| DUMC-1860-97-12R6 | None | None | None |