Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006046
Status:
TERMINATED
Last Update Posted:
2023-10-04
First Post:
2000-07-05
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Phase I Study of Humanized 3S193 Anti-Lewis-Y Antibody in Patients With Advanced Colorectal Carcinoma
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor recruitment
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 study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer
Detailed Description:
OBJECTIVES
Determine the toxicity maximum tolerated dose and pharmacokinetics of monoclonal antibody hu3S193 in patients with advanced colorectal carcinoma
Determine the immune response in these patients treated with this regimen
OUTLINE This is a dose escalation study
Patients receive monoclonal antibody hu3S193 mAb hu3S193 IV over 30 minutes to 4 hours weekly for 8 weeks followed by 2 weeks of rest Patients with stable or responding disease at week 10 receive maintenance mAb hu3S193 weekly Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of mAb hu3S193 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities
Determine the toxicity maximum tolerated dose and pharmacokinetics of monoclonal antibody hu3S193 in patients with advanced colorectal carcinoma
Determine the immune response in these patients treated with this regimen
OUTLINE This is a dose escalation study
Patients receive monoclonal antibody hu3S193 mAb hu3S193 IV over 30 minutes to 4 hours weekly for 8 weeks followed by 2 weeks of rest Patients with stable or responding disease at week 10 receive maintenance mAb hu3S193 weekly Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of mAb hu3S193 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities
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 |
|---|---|---|---|
| LUD1999-007 | OTHER | Ludwig Institute for Cancer Research | None |
| MSKCC-00005 | OTHER | None | None |