NCT02276300

HER2-Peptide Vaccination of Patients With Solid Tumors

A Phase 1 Study of Peptide Vaccination for the Treatment of Patients With Solid Tumors Moderately Expressing HER2/Neu

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Treatment of mild Endoxan application three days before Her2 vaccination
DRUG	Sargramostim	Sargramostim is part of Her2 vaccination
DRUG	HER2-Peptid-Vakzine	Her2 vaccination is supplemented by Sargramostim and Aldara Creme application
DRUG	Imiquimod	Imiquimod is part of Her2 vaccination

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-07-18
• Completion: 2018-07-13
• First posted: 2014-10-28
• Last updated: 2019-11-20

Locations

1 site across 1 country: Germany