Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005616
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-02
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Single Dose-Escalation Study of BIBH-1 in Patients With Colorectal Cancer Scheduled for Surgical Resection
Status:
COMPLETED
Status Verified Date:
2013-06
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 study the effectiveness of monoclonal antibody therapy in treating patients who have colorectal cancer
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have colorectal cancer
Detailed Description:
OBJECTIVES I Determine any toxicity associated with increasing single doses of monoclonal antibody F19 BIBH-1 administered by intravenous infusion in patients with colorectal cancer scheduled for surgical resection II Compare the pharmacokinetics biodistribution and imaging characteristics of increasing intravenous doses of iodine I 131 BIBH-1 in this patient population III Compare the BIBH-1 related human antihuman antibody HAHA serum concentration with immunologic related clinical effects in these patients IV Compare the uptake of iodine I 131 BIBH-1 in tumor to the uptake of normal tissue when administered to these patients
OUTLINE This is a dose escalation study Patients receive monoclonal antibody F19 BIBH-1 combined with iodine I 131 IV over 60 minutes Patients undergo surgical resection approximately 7 days after BIBH-1 infusion Cohorts of 3-6 patients receive escalating doses of BIBH-1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Patients are followed once during days 5-14 and then at day 30 after surgery
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 4 months
OUTLINE This is a dose escalation study Patients receive monoclonal antibody F19 BIBH-1 combined with iodine I 131 IV over 60 minutes Patients undergo surgical resection approximately 7 days after BIBH-1 infusion Cohorts of 3-6 patients receive escalating doses of BIBH-1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Patients are followed once during days 5-14 and then at day 30 after surgery
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 4 months
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 |
|---|---|---|---|
| CDR0000067753 | REGISTRY | None | None |
| BOEH-11525 | None | None | None |
| LUDWIG-LUD98-006 | None | None | None |
| NCI-G00-1756 | Registry Identifier | PDQ Physician Data Query | None |