Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00096057
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- 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.
- 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 (e.g., granzyme B, gamma interferon, and C1Q) for determining response to this drug in these patients.
* Assess markers of immunogenicity (e.g., human anti-human antibody) of this drug in these patients.
* Assess tumor markers (e.g., CA15.3 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Jonsson Comprehensive Cancer Center at UCLA🇺🇸Los Angeles, California, United States