Breast Cancer Clinical Trial
Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
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/II 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.
Full 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 (e.g., in vitro analysis of antibody-dependent cellular cytotoxicity, natural killer cell activity, complement depletion, and tumor markers CA 15.3 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 II:Patients 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer
Locally advanced or metastatic disease
No inflammatory breast cancer
Polymorphic epithelial mucin (PEM) antigen overexpression by immunohistochemistry
Previously treated with an anthracycline and a taxane in any combination for breast cancer
No more than 2 prior chemotherapy regimens, including adjuvant /neoadjuvant therapy
No more than 1 prior regimen for distant metastatic disease
Any number of prior hormonal or biologic therapy regimens allowed
Measurable disease
At least one unidimensionally measurable lesion not previously irradiated
The following are not considered measurable lesions:
Bone
Leptomeningeal disease
Ascites
Pleural/pericardial effusion
Lymphangitis cutis/pulmonis
Abdominal masses not confirmed and followed by imaging techniques
Cystic lesions
No metastases accessible to complete surgical resection
No CNS metastasis by CT scan
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Female
Menopausal status
Not specified
Performance status
WHO 0-2
Life expectancy
At least 4 months
Hematopoietic
Hemoglobin at least 10 g/dL
Neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic
Bilirubin no greater than 1.5 mg/dL
ALT and AST no greater than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases are present)
Renal
Creatinine no greater than 1.5 times ULN OR
Creatinine clearance greater than 60 mL/min
No hyperuricemia (uric acid at least 1.25 times ULN)
No hypercalcemia (calcium at least 11.5 mg/dL [corrected for serum albumin])
Cardiovascular
LVEF at least 45% by MUGA or echocardiogram within the past 4 weeks
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3-6 months after study participation
No other prior malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
No other concurrent uncontrolled comorbid illness that represents unacceptable risk in the opinion of the investigator
No legal incapacity
PRIOR CONCURRENT THERAPY:
Biologic therapy
See Disease Characteristics
More than 2 weeks since prior growth factors to aid hematologic recovery
No other concurrent immunotherapy
Chemotherapy
See Disease Characteristics
More than 4 weeks since prior cytotoxic chemotherapy
No concurrent chemotherapy for metastatic breast cancer
Endocrine therapy
See Disease Characteristics
No concurrent endocrine therapy for metastatic breast cancer
No concurrent chronic corticosteroid therapy
No concurrent high-dose corticosteroids
Radiotherapy
More than 4 weeks since prior radiotherapy except for palliation
No concurrent antitumor radiotherapy except for palliation
Surgery
More than 4 weeks since prior major surgery
Other
More than 2 weeks since prior blood transfusions to aid hematologic recovery
No participation in any other investigational drug study
No other concurrent investigational drugs
No other concurrent antitumor therapy
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There is 1 Location for this study
Los Angeles California, 90095, United States
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