MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines for Breast Adenocarcinomas
- To determine the safety and immunization efficacy of MUC1 and HER-2/neu peptide
vaccines combined with CpG oligodeoxynucleotide, sargramostim (GM-CSF), or both, as
immune adjuvants suspended in Freund's incomplete adjuvant in patients with previously
treated stage II or III adenocarcinoma of the breast.
- To describe the impact of immunization on clinical outcomes in patients with
MUC1-positive breast cancer in terms of disease-free survival and overall survival.
OUTLINE: Patients are stratified according to Her-2/neu status (positive vs negative).
Patients are randomized to 1 of 3 treatment arms.
- Arm A: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen
vaccine, two Her-2/neu peptide-based vaccines, and sargramostim (GM-CSF) subcutaneously
(SC) on day 1.
- Arm B: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen
vaccine, two Her-2/neu peptide-based vaccines (one of them different than in arm A),
and CpG oligodeoxynucleotide SC on day 1.
- Arm C: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen
vaccine, two Her-2/neu peptide-based vaccines (one of them different than in arm A; the
same as in arm B), GM-CSF, and CpG oligodeoxynucleotide SC on day 1.
In all arms, treatment repeats every 4 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity. Patients who complete 6 courses of treatment without
disease recurrence or a second primary or intolerable toxicity will go to the observation
phase of the study for up to 2 years. Patients who develop recurrent disease during the
observational phase will go to the event monitoring phase for up to 2 years.
Blood samples are collected periodically. Blood samples and tissue samples from the
patient's most recent surgery are used for correlative studies including immune responses to
T helper and CTL epitopes by Elispot and tetramer analysis; and antigenic profiling by
expression analysis of class I HLA antigens, MUC1, and HER-2 in tumor tissue.
After completion of study treatment, patients are followed periodically until disease
recurrence or for up to 2 years.
Allocation: Randomized, Primary Purpose: Treatment
Percentage of CD4+ T cells, CD8+ T cells, B cells, monocytes, and dendritic cells in a patient's peripheral blood sample as estimated by flow cytometry with a panel of monoclonal antibodies
Svetomir Markovic, MD, PhD
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|Mayo Clinic in Arizona||Scottsdale, Arizona 85259-5404|
|Mayo Clinic in Florida||Jacksonville, Florida 32224|