At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients
In Brief
A Phase 2 clinical trial evaluating SV-BR-1-GM, Cyclophosphamide, and 1 other intervention for Breastcancer and Breast Neoplasm. Completed, enrolled 24 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
See above
Low dose pre-treatment to reduce regulatory T cells
Low dose given in the vaccine site to boost the immune response