Protocol 137

Protocol 137: A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients

Patient Population

Main Criteria Only

  • Patients with Stage III-IV breast cancer treated to:
    • No evidence of disease (NED), or
    • Stable bone only disease
  • Breast cancer must be HER2 negative
  • Patients must be at least 28 days post cytotoxic chemotherapy, systemic steroids, and/or monoclonal antibody therapy, prior to enrollment
  • Patients may be taking bisphosphonates (examples: Zoledronic acid (Zometa), Alendronate sodium (Fosamax), Ibandronate (Boniva))  and/or endocrine (examples: Anastrazole (Arimidex), Exemestane (Aromasin), Fulvestrant (Faslodex)) therapy Patients must have ECOG Performance Status Score of ≤ 1 (Appendix A)
  • Adequate laboratory values
  • Patients must be at least 18 years of age
Number of Patients
  • Up to 30
Study Objectives
  • To look at how safe STEMVAC is in patients with HER2 negative advanced stage breast cancer
  • To look at the effect of STEMVAC on the immune system when given to patients with HER2 negative advanced stage breast cancer
Treatment Information
  • Eligible patients will assigned sequentially to one of three arms defined by vaccine dose.  At each dose-level, the 3rd patient enrolled will be at least 1 month from their last vaccination before any other patients are enrolled.
On-Site Study Visits
  • STEMVAC vaccines will be given during Month 1, 2, and 3
  • Follow-up visit during Month 4
  • Booster STEMVAC vaccines given during Month 6 and Month 12
  • Follow-up visit during Month 15
Long-term Follow-up
  • Information on how the patient is doing will be obtained from patient’s primary oncologist twice a year for up to five years after Month 15
Total Visits
  • 7 visits at the University of Washington Medical Center-Clinical Research Center
Other Procedures During Study Visits
  • History and physicals
  • Tetanus vaccine at first visit only
  • Monthly pregnancy test if needed
  • Clinical blood tests plus research blood to do immune monitoring
Study Location:

University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195

ClinicalTrials.gov Identifier: NCT02157051

Contact Information:

866-932-8588
Email
trialtvg@uw.edu

Clinical Trials Contact

For more information regarding our trials, please call our Patient Coordinator

866-932-8588
Email