Investigation of peptide vaccination targeting HER2/neu in patients with metastasized breast or gastric cancer with moderate HER2/neu expression.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Treatment of mild Endoxan application three days before Her2 vaccination
Sargramostim is part of Her2 vaccination
Her2 vaccination is supplemented by Sargramostim and Aldara Creme application
III.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der TUM
Munich, Bavaria, Germany
Safety and tolerability of HER2-derived peptide vaccination measured by clinical and chemical parameters.
To examine the safety and tolerability of HER2-derived peptide vaccination in patients with stage IV metastasized breast or gastric cancer with documented stable disease or objective response after at least first line systemic chemotherapy/radiotherapy for advanced disease.
Time frame: Safety measurement will be assessed up to 113 days relating to start of study treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Imiquimod is part of Her2 vaccination