General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT03862430

Background Information

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.

Offered At

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031
Principal Investigator

Adam Cohen, MD

Eligibility Information

  • Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme
  • Treatment plan includes 60 Gy of focal radiation administration in 30 fractions, concurrently with temozolomide chemotherapy.
  • Aged 18 years and older.
  • Karnofsky Performance Status ≥ 70.
  • Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
  • Women of childbearing potential or men with child-bearing potential partners (unless vasectomized) must agree to use a highly-effective method of birth control from study entry until 4 months after completing study therapy.
  • Ability to understand and the willingness to sign a written informed consent document.

Ineligibility Information

  • Recurrent glioblastoma.
  • Prior treatment for glioblastoma apart from surgical resection.
  • Presence of multifocal glioblastoma that cannot be encompassed into a radiation treatment field that would be safely treated to the prescribed radiation dose.
  • Presence of leptomeningeal disease that cannot be encompassed within a feasible and safe radiation field.
  • Intracranial bleeding, except for stable grade 1 hemorrhage or a post-operative bleed that is clearing.
  • Stroke or transient ischemic attack requiring hospitalization within 6 months before enrollment.
  • Myocardial infarction within 6 months before enrollment, unstable angina, New York Heart Association class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg).
  • Known history of congenital long QT syndrome.
  • Clinically-significant chronic obstructive pulmonary disease or asthma.
  • Active major infection requiring treatment.
  • A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
  • Known infection with human immunodeficiency virus or hepatitis B or C virus.

  • Women who are pregnant or breast feeding.

    For more information visit:  https://clinicaltrials.gov/study/NCT03862430