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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy  Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
For Condition: stage 3B breast cancer,stage 4 breast cancer,stage 3A breast cancer,stage 3C breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. - 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkPegram, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Mark Pegram 310-206-6880
Additional Information:
Study ID Numbers: CDR0000316264; ANTISOMA-ASM-THEREX-01,ANTISOMA-TOPCAT,UCLA-0212097
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066547
Other Stage 3c Breast Cancer Studies:
1. Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
2. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
3. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
4. Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
5. Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
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Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
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