Oxygen therapy shows promise in brain cancer fight
NCT ID NCT03862430
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests whether adding an experimental drug called NanO2 to standard radiation and chemotherapy can help people with newly diagnosed glioblastoma, an aggressive brain cancer. NanO2 is designed to deliver more oxygen to tumors, which may make radiation work better. About 87 adults will take part, and researchers will track how long the cancer stays under control and overall survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 87 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2023
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme. 2. Treatment plan includes 60 Gy of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy. 3. Manageable risks associated with potential radiation necrosis in the radiation field, based on size of the field and proximity to eloquent brain regions (as assessed by the investigator). 4. Aged 18 years and older. 5. Karnofsky Performance Status ≥ 70 6. Life expectancy of at least 3 months. 7. Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans. 8. Baseline MRI performed within 7 days before starting study treatment while on a stable or decreasing glucocorticoid dose for at least 7 days before and during the imaging study. 9. Adequate hematologic, renal and hepatic function, as defined by: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L 2. Platelet count ≥ 75 x 109/L 3. Hemoglobin ≥ 10.0 g/dl 4. Serum creatinine \< 1.5 x ULN 5. Total bilirubin within normal limits (≤ 2.5 x ULN if Gilbert's syndrome) 6. Aspartate transaminase (AST) and Alanine transaminase (ALT) \< 2.5 x ULN 10. 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. 11. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria 1. Recurrent Glioblastoma 2. Prior treatment for glioblastoma apart from surgical resection. 3. Presence of multi-focal glioblastoma disease that cannot be encompassed into a radiation treatment field that would be safely treated to the prescribed radiation dose. 4. Presence of leptomeningeal disease that cannot be encompassed within a feasible and safe radiation field. 5. Intracranial bleeding, except for stable grade 1 hemorrhage or a post-operative bleed that is clearing. 6. Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits. 7. Subjects who have received any other investigational agent within 4 weeks before enrollment 8. Stroke or transient ischemic attack requiring hospitalization within 6 months before enrollment. 9. Myocardial infarction (MI) within 6 months before enrolment, unstable angina, New York Heart Association (NYHA) class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP \> 160 mmHg and/or diastolic BP \> 100 mmHg). 10. Known History of Congenital long QT syndrome (12-lead EKG is not required). 11. Clinically significant chronic obstructive pulmonary disease or asthma. 12. Active major infection requiring treatment. 13. A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancers or other solid tumors curatively treated with no evidence of disease for ≥ 2 years. 14. Known infection with human immunodeficiency virus or hepatitis B or C virus (testing is not required). 15. Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins, low-dose aspirin, rivaroxaban (Xarelto®), apixaban (Eliquis®), or dabigatran (Pradaxa®). 16. History of allergic reactions attributed to compounds of similar chemical composition to NanO2. 17. Women who are pregnant or breast feeding. 18. Inability to comply with study procedures. 19. History or evidence of any other clinically significant condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with study procedures, evaluation or completion. 20. Known hypersensitivity to any temozolomide component or to dacarbazine (DTIC).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Glioblastoma multiforme are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Atlantic Health System
Summit, New Jersey, 07901, United States
-
Center for Neurosciences
Tucson, Arizona, 85718, United States
-
Duke University Medical Center
Durham, North Carolina, 27710, United States
-
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
-
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
-
Providence St. John's Cancer Institute
Santa Monica, California, 90404, United States
-
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
-
St. Francis Medical Center, OSF Healthcare
Peoria, Illinois, 61637, United States
-
UC Irvine Health- Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
-
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106, United States
-
University of Arizona
Tucson, Arizona, 85719, United States
-
Yale Cancer Center
New Haven, Connecticut, 06520, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug targets Sugar-Coated proteins on cancer cells
- Off-the-Shelf immune cells target solid tumors
- Could a parasite drug fight childhood brain tumors?
- Can mapping the Blood-Brain barrier in brain tumors unlock new clues?
- Can a pill that starves tumors of oxygen help fight advanced cancer?
- Brain cancer vaccine targets survivin protein to boost immune attack