A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM (NCT03862430) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM
United States87 participantsStarted 2023-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme.
. Treatment plan includes 60 Gy of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
. 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).
. Aged 18 years and older.
. Karnofsky Performance Status ≥ 70
. Life expectancy of at least 3 months.
. Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. Recurrent Glioblastoma
. Prior treatment for glioblastoma apart from surgical resection.
. 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.
. 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.
. Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
. Subjects who have received any other investigational agent within 4 weeks before enrollment
. Stroke or transient ischemic attack requiring hospitalization within 6 months before enrollment.