Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025532
Status:
WITHDRAWN
Last Update Posted:
2012-09-14
First Post:
2001-10-11
Brief Title:
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Pre-Phase I Biodistribution Study Of hCCCH2 Labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas
Status:
WITHDRAWN
Status Verified Date:
2012-09
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 deliver tumor-killing substances to them without harming normal cells This may be an effective treatment for gastrointestinal cancer
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have gastrointestinal cancer
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have gastrointestinal cancer
Detailed Description:
OBJECTIVES I Determine the biodistribution and biokinetics of iodine I 131-labeled monoclonal antibody CC49-delta CH2 in patients with gastrointestinal adenocarcinoma II Determine the human anti-human monoclonal antibody response in patients treated with this drug
OUTLINE Patients receive iodine I 131-labeled monoclonal antibody CC49-delta CH2 131I MOAB CC49-delta CH2 IV over 5-10 minutes on day 0 Patients also receive unlabeled monoclonal antibody CC49-delta CH2 IV over 5 minutes followed by 131I MOAB CC49-delta CH2 IV over 5-10 minutes on day 28 Patients are followed weekly for 4 months and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 1 year
OUTLINE Patients receive iodine I 131-labeled monoclonal antibody CC49-delta CH2 131I MOAB CC49-delta CH2 IV over 5-10 minutes on day 0 Patients also receive unlabeled monoclonal antibody CC49-delta CH2 IV over 5 minutes followed by 131I MOAB CC49-delta CH2 IV over 5-10 minutes on day 28 Patients are followed weekly for 4 months and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| UCSF-H11156-18101-02 | None | None | None |
| UCSF-00455 | None | None | None |
| NCI-T97-0054 | None | None | None |