Phase I Trial of Intratumoral Administration of NIS Expressing Strain of Measles Virus in Unresectable or Recurrent Malignant Peripheral Nerve Sheath Tumor
Abstract
Study approved by Mayo IRB on April 18, 2016, and by USAMRMC/ORP/HRPO on May 6, 2016. All study staff completed IRB training. Dose volume charts have been developed to facilitate pharmacy orders. Study opened for enrollment on May 17, 2016. Study coordinators identified and assigned to the study by Mayo Clinic Cancer Center. Seven patients have been enrolled in the study. They completed treatment per protocol and continue the follow up. None of the treated patients experienced side effects. Three patients completed treatment at the first dose level, and three patients have been treated by dose 2 level. We enrolled and treated one patient into dose level 3 and his is undergoing follow up per protocol. Accrual of additional patients into dose 3 level is ongoing. A few additional patients are under evaluation for eligibility at this time. We anticipate next patient to be evaluated in late October or early November 2021 (international patient, arrival was delayed because of ongoing local treatment and current epidemiologic situation related to Covid-19). So far out of 7 treated patients 6 experienced tumor progression. The first patient treated with dose level 3 is undergoing follow up. None of patients experienced side effects and there was no documented viral shedding, so we did not reach dose limiting toxicity at the level 1 and 2 dosing. Nuclear imaging documented presence of viral particles 8 days after MV-NIS intratumoral injections and tumor biopsies were positive for viral DNA, but imaging and DNA studies were negative on later timepoints.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2021
- Accession Number
- AD1152302
Entities
People
- Dusica Babovic-vuksanovic
Organizations
- Mayo Clinic