Immunotherapeutic Strategies in Breast Cancer: Preclinical and Clinical Trials
Abstract
This project is focused on novel tumor vaccines directed at MUC1 and other tumor antigens. Our specific aims are: 1) To assess the effectiveness of vaccines against MUC1 and other tumor antigens in the prevention and treatment of spontaneous breast carcinomas in mice; 2) To translate an effective vaccine strategy into a phase I clinical trial in patients with undetectable disease following standard therapy. The model of spontaneous mammary cancer is the MUC1-expressing polyoma middle T antigen mice (MMT). We have tested five vaccines in the preclinical mouse model and all elicited a strong immune response. The vaccine using MUC1 class I binding peptides prevented MUC1-expressing tumor growth. We have designed the Phase I clinical trial using a peptide vaccine comprised of MUC1 and HER-2/neu MHC class I peptides and HER-2/neu MHC class II peptide with unmethylated CpG oligodeoxynucleotides and GM-CSF as adjuvants in breast cancer patients free of disease. The clinical trial was unanimously approved by the Mayo Institutional Review Board (IRB 582-05) following receipt of FDA approval (BB-IND 12155) and by the DoD HSRRB in January 2007 and HRPO on June 9, 2008. The clinical trial opened August 28, 2008. Thirty-nine patients have been enrolled. The trial is closed to accrual.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2011
- Accession Number
- ADA552753
Entities
People
- Sandra J. Gendler
Organizations
- Mayo Clinic Scottsdale