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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Giving laboratory-treated T cells after chemotherapy may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well giving laboratory-treated T cells after second-line chemotherapy works in treating women with HER2/neu-negative metastatic breast cancer.
- To determine whether treatment with anti-CD3 x anti-HER2/neu bispecific antibody-armed activated T-cells (ATC) after second-line chemotherapy and lymphodepletion using cyclophosphamide improves median progression-free survival (PFS) by 3 months beyond the median PFS of 6 months reported in published trials in women with HER2/neu-negative metastatic breast cancer.
- To confirm the toxicity profile of anti-CD3 x anti-HER2/neu bispecific antibody-armed ATC given after second-line chemotherapy and lymphodepletion using cyclophosphamide in these patients.
- To measure functional and phenotypic changes in immune cell populations in blood and tumor samples (if accessible) as a consequence of immunotherapy (i.e., cytokine responses, phenotypic markers of differentiation, and antitumor cytotoxicity).
- To develop correlates between systemic or tumor site immune responses and clinical outcomes.
OUTLINE: Patients receive second-line chemotherapy for 4 courses or 4 months. Beginning 4 weeks after completion of chemotherapy, patients receive 1 dose of lymphodepleting chemotherapy comprising cyclophosphamide IV on day -7. Beginning on day 0, patients receive an infusion of anti-CD3 x anti-HER2/neu bispecific antibody-armed activated T-cells (ATC) IV over 30-60 minutes once a week for 3 weeks. Patients then receive a boost of anti-CD3 x anti-HER2/neu bispecific antibody-armed ATC at 12 weeks after the 3rd ATC infusion.
Blood and tumor tissue samples may be collected periodically for biomarker and other analyses.
After completion of study therapy, patients are followed up periodically for ≥ 2 years.
Masking: Open Label, Primary Purpose: Treatment
HER2Bi-armed activated T cells, cyclophosphamide, laboratory biomarker analysis
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:11:40-0400
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RATIONALE: Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Drugs used in chemotherapy, such as doxorubicin hyd...
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Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...