- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00066547
Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
An Open Label Phase I/II Study of Humanized Human Milk Fat Globule-1 (THEREX) in Patients With Locally Advanced or Metastatic Breast Cancer Following Prior Anthracycline and Taxane Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 (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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark D. Pegram, MD, Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000316264
- UCLA-0212097
- ANTISOMA-TOPCAT
- ANTISOMA-ASM-THEREX-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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