SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer
Status:
Completed
Trial end date:
2018-11-22
Target enrollment:
Participant gender:
Summary
This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast
cancer. Eligible patients will have histological confirmation of breast cancer with recurrent
and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose
cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and
upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of
inoculation ~2 and ~4 days after the inoculation. These is repeated every 2 weeks for one
month (3 treatments), then monthly for up to one year. Standard tumor assessments are
performed at baseline and then every 2-3 months.