Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00006228|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Breast Cancer Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Biological: trastuzumab Biological: aldesleukin Other: laboratory biomarker analysis Other: pharmacological study||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Anti-HER-2 Monoclonal Antibody Trastuzumab (Herceptin) in Combination With Low Dose Interleukin-2 (Proleukin) in Metastatic Breast Cancer Patients Who Have Previously Failed Trastuzumab|
|Study Start Date :||July 2000|
|Actual Primary Completion Date :||July 2003|
Experimental: Treatment (trastuzumab and aldesleukin)
Patients receive trastuzumab IV over 30-90 minutes on days 1 and 8 and aldesleukin 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.
Other: laboratory biomarker analysis
Other: pharmacological study
- Response rate using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 12 months ]
- Toxicity assessed using Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 12 months ]
- Degree of NK cell expansion [ Time Frame: Up to 12 months ]
- Effectiveness of patients' PBMCs in a standard ADCC assay directed against HER2 target cells [ Time Frame: Up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006228
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Charles Shapiro||Ohio State University|