Bastyr/威斯康星大学肿瘤真菌学转化研究中心-猫眼课题宝

Bastyr/威斯康星大学肿瘤真菌学转化研究中心

批准号：

8146214

负责人：

Mary L. Disis

金额：

$110.62万

依托单位：

BASTYR UNIVERSITY

依托单位国家：

美国

项目类别：

财政年份：

2010

资助国家：

美国

项目状态：

已结题

起止时间：

2010-09-29 至 2014-08-31

来源：

https://reporter.nih.gov/project-details/8146214

关键词：

Agaricales Agonist American Analytical Chemistry Animals Antibody Therapy Antigen-Presenting Cells Antineoplastic Agents Antitumor Response Apoptotic Asians Award Back Biological Assay Biological Markers British Budgets CD4 Positive T Lymphocytes CD8B1 gene Cancer Patient Cells Center for Translational Science Activities Clinical Clinical Trials Clinical Trials Design Collaborations Combined Modality Therapy Conduct Clinical Trials Cytotoxic T-Lymphocytes Data Defect Dendritic Cells Disease Progression Dose Drug Formulations Drug Kinetics ERBB2 gene Effector Cell Endotoxins Epitopes Evaluation External Beam Radiation Therapy Funding Genes Glucans Goals Grant Head Heavy Metals Helper-Inducer T-Lymphocyte Human Human Activities Immune Immune response Immune system Immunity Immunologics Immunotherapy Inflammatory Interferon Type II Interleukin-2 International Japan Japanese Population Knock-out Laboratories Ligands Lymphopenia Malignant neoplasm of prostate Measurable Methodology Methods Modeling Molecular Profiling Monoclonal Antibodies Mus NK Cell Activation Natural Immunity Natural Killer Cells New York Oncologist Oral Oral Administration Outcome Pathway interactions Patients Peptide Vaccines Peripheral Blood Lymphocyte Peripheral Blood Mononuclear Cell Pesticides Pharmaceutical Chemistry Phase Phase I Clinical Trials Placebo Control Placebos Play Polysaccharide-K Polysaccharides Proteomics Radiation Radiation therapy Randomized Randomized Controlled Clinical Trials Reporting Research Role Safety Science Serum Societies Staging Study Subject T-Lymphocyte TLR2 gene TLR4 gene Testing Transgenic Mice Translating Trastuzumab Treatment Effectiveness Tumor Antigens Tumor Necrosis Factor-alpha United States National Institutes of Health Up-Regulation Vaccine Therapy Vaccines Woman Work base bench to bedside beta-Glucans breast cancer vaccine cancer cell cell mediated immune response cohort cytokine cytotoxic docetaxel fungus granulocyte immunogenic immunogenicity improved in vitro Assay in vivo interest liquid chromatography mass spectrometry malignant breast neoplasm meetings men monocyte neoplastic cell olympia oncology overexpression peripheral blood pre-clinical preclinical evaluation preclinical study pressure prevent protein expression public health relevance quality assurance response symposium tumor tumor growth

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DESCRIPTION (provided by applicant): Purpose: To assess the effects of combining the TLR agonist activity of PSK to HER-2/neu (HER2) directed monoclonel antibody therapy using a HER2 specific vaccine for the treatment of patients with advanced stage breast cancer. We will conduct pre-clinical gene-signature biomarker work in year 1 and 2 then conduct a placebo-controlled phase II randomized controlled clinical trial in years 3 and 4. Hypothesis: PSK, when added to a HER2 vaccine will improve immune response and Survival in women with advanced HER2 overexpressing breast cancer. Methods: 1) Determine whether PSK administered concurrently with HER2-targeted vaccine can enhance tumor antigen-specific immune response and prevent or delay disease progression in neu-transgenic mice; 2) Identify a gene signature that predicts clinical response in neu-transgenic mice receiving PSK, trastuzumab, and a HER2-tergeted vaccine; and 3) Determine the safety and immunogenicity of PSK as a component of combination immunotherapy in patients with advanced stage (stage IV) breast cancer. Clinical Trial Design: 30 women with advenced HER-2/neu overexpressing breast cancer who receive trastuzumab + HER2 peptide vaccine therapy will be randomized to receive PSK or placebo orally (3000 mg/day) concomitant with vaccine therapy. Primary endpoints will be intermolecular epitope spreading, changes in TGF-b serum levels and peripheral blood biomarkers identified in neu-transgenic mice as predictive of clinical response in breast cancer patients receiving HER2 ICD vaccine. PUBLIC HEALTH RELEVANCE: Trametes versicolor is an immunologically active medicinal mushroom that is likely to improve the effectiveness of treatments for women with advanced breast cancer. We will investigate the effect of oral doses of PSK, a T. versicolor extract prescribed in Japan as a cancer drug, in augmenting the anticancer immune response in advanced breast cancer.

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