Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066547
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2003-08-06
Brief Title:
Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Phase III Study of Humanized Human Milk Fat Globule-1 THEREX in Patients With Locally Advanced or Metastatic Breast Cancer Following Prior Anthracycline and Taxane Therapy
Status:
UNKNOWN
Status Verified Date:
2004-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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 III trial to study the effect of monoclonal antibody therapy on the body and its effectiveness in treating women who have locally advanced or metastatic breast cancer that was previously treated with combination chemotherapy
PURPOSE Phase III trial to study the effect of monoclonal antibody therapy on the body and its effectiveness in treating women who have locally advanced or metastatic breast cancer that was previously treated with combination chemotherapy
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with locally advanced or metastatic breast cancer previously treated with anthracycline and taxane-based therapy
Determine the maximum tolerated dose and appropriate schedule of this drug in these patients
Determine the pharmacokinetic profile of this drug in these patients
Determine the tumor response rate progression-free survival and median survival of patients treated with this drug
Analyze immunological markers for evaluation of disease status eg in vitro analysis of antibody-dependent cellular cytotoxicity natural killer cell activity complement depletion and tumor markers CA 153 and CEA in patients treated with this drug
OUTLINE This is a dose-escalation open-label nonrandomized multicenter study
Phase I Patients receive monoclonal antibody HuHMFG1 IV over 1-3 hours once every 3 weeks for doses 1 and 2 All subsequent dose intervals are based on individual half-life value of the drug Patients receive at least 6 doses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuHMFG1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase IIPatients receive monoclonal antibody HuHMFG1 as above at the MTD Patients are followed at 28 days
PROJECTED ACCRUAL Approximately 3-40 patients 3-15 patients for phase I and 19-25 patients for phase II will be accrued for this study within approximately 12 months
Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with locally advanced or metastatic breast cancer previously treated with anthracycline and taxane-based therapy
Determine the maximum tolerated dose and appropriate schedule of this drug in these patients
Determine the pharmacokinetic profile of this drug in these patients
Determine the tumor response rate progression-free survival and median survival of patients treated with this drug
Analyze immunological markers for evaluation of disease status eg in vitro analysis of antibody-dependent cellular cytotoxicity natural killer cell activity complement depletion and tumor markers CA 153 and CEA in patients treated with this drug
OUTLINE This is a dose-escalation open-label nonrandomized multicenter study
Phase I Patients receive monoclonal antibody HuHMFG1 IV over 1-3 hours once every 3 weeks for doses 1 and 2 All subsequent dose intervals are based on individual half-life value of the drug Patients receive at least 6 doses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuHMFG1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase IIPatients receive monoclonal antibody HuHMFG1 as above at the MTD Patients are followed at 28 days
PROJECTED ACCRUAL Approximately 3-40 patients 3-15 patients for phase I and 19-25 patients for phase II will be accrued for this study within approximately 12 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANTISOMA-ASM-THEREX-01 | None | None | None |
| UCLA-0212097 | None | None | None |
| ANTISOMA-TOPCAT | None | None | None |