NCT00096057

Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	monoclonal antibody HuHMFG1

Timeline

• Start date: 2004-05-01
• Completion: 2007-12-01
• First posted: 2004-11-09
• Last updated: 2013-06-26

Locations

3 sites across 1 country: United States