Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around

Description

Summary

This clinical trial is testing the safety and efficacy of NanO2TM administered via intravenous infusion in combination with standard radiation and chemotherapy.

NanO2TM is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.

Official Title

A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE: RESTORE

Details

All study participants will receive standard care for GBM including Temozolomide and radiation therapy. Subjects will be randomized on a 2 to 1 basis to receive either NanO2 infusions or saline infusions immediately prior to standard radiation therapy. Radiation therapy is performed 5 days a week for 6 weeks.

Radiation therapy is followed 28 days of recovery, and then six cycles of maintenance Temozolomide therapy on days 1 to 5 of six 28 day cycles.

Follow up will be every 3 months for 3 years, and then every 6 months for another 2 years.

Keywords

Glioblastoma Multiforme, Glioblastoma, NanO2TM

Eligibility

Locations

  • UC Irvine Health- Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • Providence St. John's Cancer Institute accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NuvOx LLC
ID
NCT03862430
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 87 study participants
Last Updated