Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096057
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2004-11-09
Brief Title:
Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Phase I Study of Humanized Human Milk Fat Globule-1 huHMFG1 Antibody in Patients With Locally Advanced or Metastatic Breast Cancer TOPCAT
Status:
COMPLETED
Status Verified Date:
2007-04
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 such as HuHMFG1 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE This phase I trial is studying the side effects and best dose of monoclonal antibody HuHMFG1 in treating women with locally advanced or metastatic breast cancer
PURPOSE This phase I trial is studying the side effects and best dose of monoclonal antibody HuHMFG1 in treating women with locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with locally advanced or metastatic breast cancer
Determine a safe recommended dose and schedule of this drug in these patients
Determine the pharmacokinetic profile in the absence of any other chemotherapy or endocrine agent of this drug in these patients
Determine the antitumor activity of this drug in these patients
Determine time to progression in patients treated with this drug
Assess immunological markers eg granzyme B gamma interferon and C1Q for determining response to this drug in these patients
Assess markers of immunogenicity eg human anti-human antibody of this drug in these patients
Assess tumor markers eg CA153 and CEA in patients treated with this drug
Correlate preliminarily soluble HMFG1 antigen levels with pharmacokinetic data for this drug in these patients
OUTLINE This is an open-label non-randomized dose-escalation study
Patients in cohorts 1 and 2 receive monoclonal antibody HuHMFG1 IV over 1-3 hours once every 21 days for doses 1 and 2 All subsequent dose intervals are based on individual half-life value of the drug to be within 3 days of the estimated half-life in multiples of 7 days Patients in cohorts 3 and 4 receive monoclonal antibody HuHMFG1 at the dosing interval determined in the first 2 cohorts Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 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 6 patients experience dose-limiting toxicity
All patients are followed at 4 weeks and then every 6 weeks for 6 months Patients with an antitumor response or stable disease are followed every 12 weeks until disease progression or initiation of another antitumor treatment
PROJECTED ACCRUAL A total of 6-24 patients will be accrued for this study within 18 months
Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with locally advanced or metastatic breast cancer
Determine a safe recommended dose and schedule of this drug in these patients
Determine the pharmacokinetic profile in the absence of any other chemotherapy or endocrine agent of this drug in these patients
Determine the antitumor activity of this drug in these patients
Determine time to progression in patients treated with this drug
Assess immunological markers eg granzyme B gamma interferon and C1Q for determining response to this drug in these patients
Assess markers of immunogenicity eg human anti-human antibody of this drug in these patients
Assess tumor markers eg CA153 and CEA in patients treated with this drug
Correlate preliminarily soluble HMFG1 antigen levels with pharmacokinetic data for this drug in these patients
OUTLINE This is an open-label non-randomized dose-escalation study
Patients in cohorts 1 and 2 receive monoclonal antibody HuHMFG1 IV over 1-3 hours once every 21 days for doses 1 and 2 All subsequent dose intervals are based on individual half-life value of the drug to be within 3 days of the estimated half-life in multiples of 7 days Patients in cohorts 3 and 4 receive monoclonal antibody HuHMFG1 at the dosing interval determined in the first 2 cohorts Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 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 6 patients experience dose-limiting toxicity
All patients are followed at 4 weeks and then every 6 weeks for 6 months Patients with an antitumor response or stable disease are followed every 12 weeks until disease progression or initiation of another antitumor treatment
PROJECTED ACCRUAL A total of 6-24 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| CDR0000391212 | REGISTRY | PDQ Physician Data Query | None |
| UCLA-0402065-01 | None | None | None |