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 MUC1 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 amended clinical trial documents, which have been accepted by Colonel Brosch of the HSRRB on July 24, 2006, have been submitted to the Mayo IRB for approval. Approval should be forthcoming shortly. The approval notice and the documents reviewed and approved by the Mayo IRB will then be resubmitted to the HSRRB in order to obtain an Approval Memorandum prior to opening the clinical trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2006
- Accession Number
- ADA469352
Entities
People
- Sandra J. Gendler
Organizations
- Mayo Clinic Scottsdale