Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006099
Status:
TERMINATED
Last Update Posted:
2023-10-04
First Post:
2000-08-03
Brief Title:
Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Pilot Trial of Humanized 3S193 Monoclonal Antibody hu3S193 in Presurgical Patients With Ovarian Cancer
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low study accrual
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 Giving monoclonal antibodies in different ways may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian cancer
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian cancer
Detailed Description:
OBJECTIVES The primary objective iss to determine the safety of indium 111In monoclonal antibody mAb hu3S193 111In-hu3S193 given intraperitoneally or intravenously in patients with ovarian carcinoma
Secondary objectives include comparing the localization of 111In-hu3S193 in ovarian cancer tissue after intraperitoneal vs intravenous injection and the biodistribution and pharmacokinetics of this drug when administered intraperitoneally vs intravenously in these patients as well as the formation of human anti-human antibodies HAHA in these patients
OUTLINE Patients are assigned to 1 of 2 treatment arms on a first come sequential basis Arm I Patients receive indium In 111 monoclonal antibody hu3S193 111In-hu3S193 intraperitoneally over 30 minutes Arm II Patients received 111In-hu3S193 intravenously IV over 30 minutes Patients were to undergo surgical debulking 3-7 days following In 111In-hu3S193 administration and biopsy samples obtained to assess radioactive uptake Immunohistochemistry was also to be performed Blood samples were to be obtained to assess serum radioactivity Whole body imaging was tp be performed 3 hours after infusion of radiolabeled monoclonal antibody on the day of surgery and at one time point in between Patients were followed for 30 days
PROJECTED ACCRUAL A total of 10 patients 5 per arm were to be accrued for this study
Secondary objectives include comparing the localization of 111In-hu3S193 in ovarian cancer tissue after intraperitoneal vs intravenous injection and the biodistribution and pharmacokinetics of this drug when administered intraperitoneally vs intravenously in these patients as well as the formation of human anti-human antibodies HAHA in these patients
OUTLINE Patients are assigned to 1 of 2 treatment arms on a first come sequential basis Arm I Patients receive indium In 111 monoclonal antibody hu3S193 111In-hu3S193 intraperitoneally over 30 minutes Arm II Patients received 111In-hu3S193 intravenously IV over 30 minutes Patients were to undergo surgical debulking 3-7 days following In 111In-hu3S193 administration and biopsy samples obtained to assess radioactive uptake Immunohistochemistry was also to be performed Blood samples were to be obtained to assess serum radioactivity Whole body imaging was tp be performed 3 hours after infusion of radiolabeled monoclonal antibody on the day of surgery and at one time point in between Patients were followed for 30 days
PROJECTED ACCRUAL A total of 10 patients 5 per arm were to be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| MSKCC-00047 | OTHER | None | None |
| NCI-G00-1828 | OTHER | None | None |
| LUD1998-013 | OTHER | Ludwig Institute for Cancer Research | None |