Expired Study
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Columbus, Ohio 43210


Purpose:

Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill breast cancer cells. Phase II trial to study the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic breast cancer that has not responded to previous trastuzumab therapy.


Study summary:

PRIMARY OBJECTIVES: I. To estimate the response rate and toxicity to low-dose IL-2 with intermediate-"pulse" dose interleukin 2 (IL-2) and trastuzumab in patients with uni-dimensional measurable metastatic breast cancer and human epidermal growth factor receptor 2 (HER2) positive (3+ overexpression by immunohistochemistry [IHC] method or positive by fluorescent in situ hybridization [FISH]) who either have had evidence of progressive disease while receiving a trastuzumab-containing regimen, or have had progressive disease within 12 months of receiving a trastuzumab-containing regimen. SECONDARY OBJECTIVES: I. To perform correlative immunologic assays to determine the degree of natural killer (NK) cell expansion in response to low-dose IL-2, and the effectiveness of patients' peripheral blood mononuclear cells (PBMC) in a standard antibody-dependent cell-mediated cytotoxicity (ADCC) assay directed against a HER2 target cell. II. To determine the pharmacokinetics of trastuzumab using an every 2-week schedule. III. To determine Fc-gamma receptor polymorphisms from study patients. OUTLINE: This is a multicenter study. Patients receive trastuzumab intravenously (IV) over 30-90 minutes on days 1 and 8 and aldesleukin subcutaneously (SC) on days 2-7 and 9-21. Beginning on day 22, patients receive trastuzumab IV over 30 minutes every 14 days. Patients also receive aldesleukin SC daily on days 1-14. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 30 days. PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.


Criteria:

Inclusion Criteria: - Histologically or cytologically confirmed breast cancer - Primary and/or metastatic disease - HER2 overexpression 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) - Tumors with HER2 2+ overexpression by IHC allowed if confirmed by FISH - Progressive disease during or within 12 months of receiving prior regimen containing trastuzumab (Herceptin) - Unidimensionally measurable disease - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - The following are not considered measurable: - Bone metastases - Pleural or peritoneal effusion - Ascites - Leptomeningeal disease - Lymphangitic disease - Inflammatory breast cancer - Cystic lesions - CNS lesions - CNS metastases allowed if all of the following conditions are met: - Asymptomatic - At least 3 months since prior surgery and/or cranial irradiation - At least 3 weeks since prior steroids - Hormone receptor status: - Not specified - Male or female - Performance status - ECOG 0-2 - Granulocyte count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT and SGPT no greater than 2 times ULN (5 times ULN for liver metastases) - Alkaline phosphatase no greater than 2 times ULN (5 times ULN for liver metastases) - Creatinine no greater than 1.5 times ULN - LVEF at least lower limit of normal by MUGA or echocardiogram - No congestive heart failure or active ischemic heart disease - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No psychiatric illness, medical condition, or uncontrolled infection that would preclude study - No underlying immunodeficiency (e.g., HIV or autoimmune disease) - No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - See Disease Characteristics - Prior cumulative doxorubicin dose no greater than 360 mg/m^2 - At least 3 weeks since prior chemotherapy - No more than 2 prior chemotherapy regimens for metastatic disease - No concurrent chemotherapy - See Disease Characteristics - At least 3 weeks since prior endocrine therapy - No concurrent corticosteroids or dexamethasone - Concurrent hormones allowed for conditions unrelated to disease (e.g., insulin for diabetes) - See Disease Characteristics - At least 3 weeks since prior radiotherapy - No prior radiotherapy to study lesion, unless evidence of disease progression - No concurrent palliative radiotherapy - See Disease Characteristics - At least 4 weeks since prior major surgery - No concurrent immunosuppressive drugs


NCT ID:

NCT00006228


Primary Contact:

Principal Investigator
Charles Shapiro
Ohio State University


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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