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Immunotherapeutic Strategies in Breast Cancer: Preclinical and Clinical Trials
Annual rept. 15 Aug 2008-14 Aug 2009
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 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. Following receipt of the approvals, Pfizer agreed to supply the CpG7909PF-3512676 for the clinical trial, as Pfizer has licensed the CpG from Coley Pharmaceuticals. Amended documents showing the change in supplier of CpG were submitted to the DoD HSRRB for final approval and to the FDA. Final approval from the DoD HRPO was received June 9, 2008. The clinical trial opened August 28, 2008. Thirty-one patients have been enrolled.
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