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Brief Title: HER2-Peptide Vaccination of Patients With Solid Tumors
Official Title: A Phase 1 Study of Peptide Vaccination for the Treatment of Patients With Solid Tumors Moderately Expressing HER2/Neu
Study ID: NCT02276300
Brief Summary: Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast or gastric cancer with moderate HER2/neu expression.
Detailed Description: This is an interventional phase I clinical study to investigate the safety, tolerability and efficacy of HER2-derived peptide vaccination. HLA-A2+ patients with stage IV metastasized breast or gastric cancer with HER2 expression (IHC Score 2+) without gene amplification proved by FISH analysis, with documented stable disease or objective response after at least first line systemic chemotherapy/radiotherapy for advanced disease who have not been treated for the underlying malignant disease for 4 weeks with chemo-, radio- or immunotherapy will be included into the study. The aim of the study is to show safety and tolerability of this immunotherapeutic approach and to investigate efficacy of the immunotherapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM, Munic, Bavaria, Germany
Name: Angela Krackhardt, Prof.Dr.med.
Affiliation: III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM
Role: PRINCIPAL_INVESTIGATOR