Immunotherapeutic Strategies in Breast Cancer: Preclinical and Clinical Trials
Annual rept. 15 Aug 2004-14 Aug 2005
MAYO CLINIC SCOTTSDALE AZ
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This project is focused on novel tumor vaccines directed at MUC1 and other tumor antigens. Our specific aims are 1To assess the effectiveness of vaccines against MUC1 and other tumor antigens in the prevention and treatment of spontaneous breast carcinomas in mice 2To 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-2neu MHC class I peptides and HER-2neu 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- 2neu 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.
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