Title: Examining Oncolytic Poliovirus Bioactivity in Tumor Tissue After Intratumoral Administration of PVSRIPO in Women With Invasive Breast Cancer
Principal Investigator: Darell Bigner, MD, PhD, Istari Oncology, Inc.
Description: Researchers are conducting a pilot study to examine PVSRIPO bioactivity in tumor tissue after intratumoral administration of PVSRIPO in women with invasive breast cancer. PVSRIPO is the live attenuated, oral (Sabin) serotype 1 poliovirus vaccine containing a heterologous internal ribosomal entry site (IRES) derived from the human rhinovirus type 2 (HRV2).
The researchers hypothesize that administration of PVSRIPO in the tumor causes inflammation, which will stimulate innate and adaptive immune activation in women with invasive breast cancer. The reseachers are seeking to enroll 6 women with invasive breast cancer.
The objective of the study is to investigate PVSRIPO-mediated inflammation and immunity in women invasive breast cancer. The primary exploratory objective is to describe the change in the amount of tumor infiltrating immune cells in tumor tissue pre- and post-injection of PVSRIPO.
Women with stage 2-4 invasive breast cancer with at least 1 cm of residual tumor after chemotherapy and scheduled for standard of care surgery are eligible for enrollment. To read the complete list of inclusion and exclusion criteria please refer to the reference.
Status: This trial is ongoing and recruiting patients as of June 30, 2019.
This study is sponsored by Istari Oncology, Inc.
Clinicaltrials.gov. Examining Bioactivity of PVSRIPO in Invasive Breast Cancer. NCT03564782. https://clinicaltrials.gov/ct2/show/NCT03564782. Accessed October 15, 2020.