Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004042
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
1999-12-10
Brief Title:
Monoclonal Antibody F19 in Treating Patients With Advanced or Metastatic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose-Escalation Study of BIBH-1 in Patients With Advanced or Metastatic Fibroblast Activation Protein-Positive Cancer
Status:
COMPLETED
Status Verified Date:
2009-12
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 F19 in treating patients who have advanced or metastatic cancer
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody F19 in treating patients who have advanced or metastatic cancer
Detailed Description:
OBJECTIVES I Identify the toxicity associated with increasing doses of monoclonal antibody F19 BIBH-1 administered weekly by intravenous infusion in patients with unresectable advanced or metastatic fibroblast activation protein-positive colorectal cancer II Determine the dose limiting toxicity and maximum tolerated dose of this drug in these patients III Measure induction titers of human anti-human antibody to BIBH-1 and correlate immunologic-related clinical effects IV Determine the pharmacokinetics biodistribution and imaging characteristics of increasing intravenous doses of the drug V Document tumor responses in this patient population
OUTLINE This is a dose escalation open label multicenter study Patients receive monoclonal antibody F19 BIBH-1 IV over 60 minutes weekly for 12 weeks The first fifth and ninth treatments are combined with iodine I 131 Patients with stable or responding disease may continue treatment for up to 12 months The dose of BIBH-1 is escalated in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed at 1 month
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study within 8 months
OUTLINE This is a dose escalation open label multicenter study Patients receive monoclonal antibody F19 BIBH-1 IV over 60 minutes weekly for 12 weeks The first fifth and ninth treatments are combined with iodine I 131 Patients with stable or responding disease may continue treatment for up to 12 months The dose of BIBH-1 is escalated in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity Patients are followed at 1 month
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study within 8 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 |
|---|---|---|---|
| NCI-H99-0025 | Registry Identifier | PDQ Physician Data Query | None |
| MSKCC-98068 | None | None | None |
| LUDWIG-LUD98-002 | None | None | None |
| CDR0000066903 | REGISTRY | None | None |