Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is most effective in treating breast cancer.
PURPOSE: This randomized clinical trial is studying the side effects of three different vaccine therapies and comparing the vaccines to see how well they work in treating patients with previously treated stage II or stage III breast cancer.
Biological: CpG oligodeoxynucleotide
Biological: HER-2/neu peptide vaccine
Biological: MUC-1 peptide vaccine
Biological: incomplete Freund's adjuvant
Other: immunoenzyme technique
Other: immunologic technique
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines for Breast Adenocarcinomas|
- 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 [ Designated as safety issue: No ]
- Frequency of peptide-specific IFN-gamma producing T cells and peptide-specific IL-5 producing T cells estimated by ELISPOT after in vitro stimulation with peptide-sensitized stimulator cells for MUC1 and HER-2 peptides [ Designated as safety issue: No ]
- Number and severity of hematologic and non-hematologic toxicities reported using the NCI-CTC version 3.0 criteria [ Designated as safety issue: Yes ]
- Disease-free survival, defined as the time from registration to the documentation of a first failure where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer [ Designated as safety issue: No ]
- Overall survival, defined as the time from registration to death due to any cause [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640861
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Svetomir Markovic, MD, PhD||Mayo Clinic|
|Principal Investigator:||Barbara A Pockai, M.D.||Mayo Clinic in Arizona|
|Principal Investigator:||Edith A Perez, M.D.||Mayo Clinic in Florida|