Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003082
Status:
COMPLETED
Last Update Posted:
2010-03-16
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Advanced Cancer
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
A Phase IA Trial of Combined Murine IgG Monoclonal Anti-Transferrin Receptor Antibodies E23 and A2715 in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2007-05
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 antibodies in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of monoclonal antibodies in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine the toxicities associated with a 4-hour infusion of antitransferrin receptor antibodies with one antibody administered by itself for 1 hour before the second antibody infusion is started II Determine the pharmacokinetics of monoclonal antibodies E23 and A2715
OUTLINE This is a dose escalating study Patients receive antitransferrin antibody A2715 IV over 4 hours One hour after the initiation of the A2715 infusion infusion of antibody E2-3 is added by IV piggy back In the absence of antimouse antibodies and toxic effects treatment continues once every 4 weeks in patients achieving minimal partial or complete remission Treatment ceases in patients experiencing stable or progressive disease In the absence of dose limiting toxicity in the first 3 patients treated subsequent cohorts of 6 patients each receive escalating doses of antitransferrin antibodies E23 and A2715 on the same dose schedule If dose limiting toxicity occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the MTD Patients are followed for 3 weeks
PROJECTED ACCRUAL This study will accrue 18-27 patients within 2 years
OUTLINE This is a dose escalating study Patients receive antitransferrin antibody A2715 IV over 4 hours One hour after the initiation of the A2715 infusion infusion of antibody E2-3 is added by IV piggy back In the absence of antimouse antibodies and toxic effects treatment continues once every 4 weeks in patients achieving minimal partial or complete remission Treatment ceases in patients experiencing stable or progressive disease In the absence of dose limiting toxicity in the first 3 patients treated subsequent cohorts of 6 patients each receive escalating doses of antitransferrin antibodies E23 and A2715 on the same dose schedule If dose limiting toxicity occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the MTD Patients are followed for 3 weeks
PROJECTED ACCRUAL This study will accrue 18-27 patients within 2 years
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-T96-0025 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023074 |
| P30CA023074 | NIH | None | None |
| UARIZ-HSC-95178 | None | None | None |