Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002751
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Brain Metastases
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
PROTOCOL FOR A PHASE I STUDY OF INTRATHECAL MONOCLONAL ANTIBODY FRAGMENT 131I Me1-14 Fab2 IN PATIENTS WITH NEOPLASMS METASTATIC TO THE LEPTOMENINGES
Status:
COMPLETED
Status Verified Date:
2009-10
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 III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have brain metastases
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody therapy in treating patients who have brain metastases
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of 131-iodine-labeled monoclonal antibody fragment Me1-14 Fab2 administered intrathecally in patients with neoplasms metastatic to the leptomeninges II Identify objective therapeutic responses to this treatment
OUTLINE Radioimmunotherapy Iodine-131-Labeled Monoclonal Antibody Fragment Me1-14 Fab2 131I-Me1-14 Fab2
PROJECTED ACCRUAL Three to 6 patients will be treated at each dose studied
OUTLINE Radioimmunotherapy Iodine-131-Labeled Monoclonal Antibody Fragment Me1-14 Fab2 131I-Me1-14 Fab2
PROJECTED ACCRUAL Three to 6 patients will be treated 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 |
|---|---|---|---|
| CDR0000064687 | OTHER | NCI | None |
| DUMC-1193-006R11 | None | None | None |
| DUMC-1017-96-7R7 | None | None | None |
| DUMC-1100-97-7R8 | None | None | None |
| DUMC-1159-98-7R9 | None | None | None |
| DUMC-1229-99-7R10 | None | None | None |
| DUMC-657897 | None | None | None |
| DUMC-997-95-7R6 | None | None | None |
| NCI-V90-0052 | None | None | None |
| NCI-H96-0010 | None | None | None |