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. The clinical trial has been unanimously approved by the Mayo Institutional Review Board (IRB 582-05) following receipt of FDA approval (BB-IND 12155). The peptides have been synthesized and vialed. It is a phase I trial testing MUCI and HER- 2/neu class I and class II peptides with CpG ODN and GM-CSF adjuvants in breast cancer patients free of disease. The clinical trial documents were formally submitted in May 2005 for USAMRMC approval.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2005
- Accession Number
- ADA443068
Entities
People
- Sandra J. Gendler
Organizations
- Mayo Clinic Scottsdale