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. Following receipt of the approvals, we encountered difficulties in obtaining the CpG adjuvant, as Coley Pharmaceuticals had licensed the CpG program in oncology to Pfizer during this time. Pfizer Inc. have subsequently agreed to supply this reagent. Amended documents showing the change in supplier of CpG have been submitted to the DoD HSRRB for final approval and to the FDA. Final approval from the Mayo Clinic IRB was received August 2, 2007. The clinical trial will open once all approvals have been received.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 14, 2007
- Accession Number
- ADA475107
Entities
People
- Sandra J. Gendler