Expired Study
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Aurora, Colorado 80045


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Locally advanced or metastatic disease - No inflammatory breast cancer - Measurable (RECIST) or evaluable disease (e.g., cytologically or radiologically detectable disease that does not fulfill RECIST criteria) - Failed prior OR not a candidate for OR refused anthracycline- and taxane-containing chemotherapy - Patients whose tumor overexpresses HER-2 must have failed prior trastuzumab (Herceptin®) - No known CNS metastases - No metastases accessible to complete surgical resection - Unstained slides cut from formalin-fixed and paraffin-embedded tumor blocks available - Appropriate tumor block also acceptable - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - WHO 0-1 Life expectancy - At least 4 months Hematopoietic - Hemoglobin ≥ 10 g/dL - Absolute neutrophil count ≥ 1,500/mm^3 - WBC ≥ 1,000/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin ≤ 1.5 mg/dL - ALT or AST ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN in patients with liver metastases) OR - Alkaline phosphatase ≤ 2.5 times ULN (< 5 times ULN in patients with liver metastases) - Any degree of elevated alkaline phosphatase allowed provided it is due to bone metastases Renal - Creatinine ≤ 1.5 times ULN OR - Creatinine clearance > 60 mL/min - Uric acid < 1.25 times ULN (for patients with hyperuricemia only) - Calcium (corrected for serum albumin) < 11.5 mg/dL (for patients with hypercalcemia only) Cardiovascular - LVEF ≥ 45% by MUGA or echocardiogram within the past 4 weeks Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intra-epithelial neoplasia - No other uncontrolled illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - Prior biological therapy allowed - More than 2 weeks since prior blood transfusions or growth factors to aid hematological recovery - No other concurrent antitumor immunotherapy Chemotherapy - See Disease Characteristics - More than 4 weeks since prior cytotoxic chemotherapy - No more than 3 prior chemotherapy regimens, including adjuvant/neoadjuvant therapy - No concurrent antitumor chemotherapy Endocrine therapy - Prior hormonal therapy allowed - No concurrent corticosteroids except as physiologic replacement and/or for acute short-term treatment of, or prophylaxis against, infusion reactions - No concurrent antitumor hormonal therapy Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy (except for palliative radiotherapy) - No concurrent antitumor radiotherapy, except for palliation to non-study lesions - Irradiated area should be as small as possible and involve ≤ 10% of the bone marrow in any given 4-week period Surgery - More than 4 weeks since prior major surgery Other - More than 30 days since prior investigational agents - No other concurrent investigational agents


NCT ID:

NCT00096057


Primary Contact:

Study Chair
Mark D. Pegram, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Aurora, Colorado 80045
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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