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. Eight patients have been enrolled in the study and 7 received study drug per protocol One patient withdrew from the study after enrollment and others completed treatment per protocol and 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 two patients into dose level 3, one of these patients withdrew after enrollment and another completed treatment and 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 treated in November 2023, currently undergoing standard oncology therapy. So far out of 7 treated patients 6 experienced tumor progression. 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, 2023
- Accession Number
- AD1218498
Entities
People
- Dusica Babovic-vuksanovic
Organizations
- Mayo Clinic