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Oxygen Enhancer

NanO2 for Glioblastoma (RESTORE Trial)

Phase 2
Recruiting
Research Sponsored by NuvOx LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years and older.
Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme.
Must not have
Known infection with human immunodeficiency virus or hepatitis B or C virus (testing is not required).
Presence of leptomeningeal disease that cannot be encompassed within a feasible and safe radiation field.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 months
Awards & highlights

Summary

This trial is testing a new treatment that delivers more oxygen to tumors. It aims to help patients with a specific type of brain cancer by making radiation therapy more effective. By increasing oxygen levels in the tumor, the treatment helps radiation work better at killing cancer cells.

Who is the study for?
Adults with newly diagnosed glioblastoma who can have MRI scans, have a life expectancy of at least 3 months, and are in good enough health to undergo radiation and chemotherapy. They must not be pregnant or breastfeeding, agree to use effective birth control, and cannot have had any prior treatment for glioblastoma or other significant medical conditions that could interfere with the trial.
What is being tested?
The trial is testing NanO2TM combined with standard radiation therapy and temozolomide chemotherapy. NanO2TM is designed to increase oxygen delivery to tumors which may enhance the effectiveness of radiation therapy against brain cancer.
What are the potential side effects?
While specific side effects for NanO2TM aren't listed, common side effects from similar treatments include fatigue, headache, nausea, skin irritation from radiation, low blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been newly diagnosed with glioblastoma.
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My treatment plan includes specific radiation and chemotherapy doses.
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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I know I do not have HIV or hepatitis B/C.
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My cancer has spread to the lining of my brain and cannot be safely targeted with radiation.
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I have not had a stroke or mini-stroke that needed hospital care in the last 6 months.
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I have severe long-term asthma or COPD.
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I haven't had a heart attack or severe heart issues in the last 6 months.
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I am currently being treated for a serious infection.
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I have had treatment for glioblastoma other than surgery.
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My brain cancer has come back after treatment.
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I am not pregnant or breastfeeding.
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I have a known history of long QT syndrome.
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My glioblastoma cannot be fully treated with one safe radiation dose.
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I am still recovering from surgery side effects, except for any lasting nerve issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival (PFS)
Secondary study objectives
Caregiver quality of life
Overall Survival
Patient quality of life
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NanO2TMExperimental Treatment1 Intervention
NanO2TM infusion in conjunction with Radiation Treatment and temozolomide
Group II: PlaceboPlacebo Group1 Intervention
Placebo Saline infusion in conjunction with Radiation Treatment and temozolomide

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Glioblastoma treatments typically include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible. Radiation therapy uses high-energy rays to kill cancer cells, and its effectiveness can be enhanced by increasing the oxygen supply to the tumor, as hypoxic conditions can make tumors more resistant to radiation. Chemotherapy, such as temozolomide, damages the DNA of cancer cells, preventing their growth. The trial involving NanO2TM focuses on increasing oxygen delivery to tumors, which is crucial because better-oxygenated tumors respond more effectively to radiation therapy, potentially improving treatment outcomes for Glioblastoma patients.

Find a Location

Who is running the clinical trial?

NuvOx LLCLead Sponsor
4 Previous Clinical Trials
335 Total Patients Enrolled
1 Trials studying Glioblastoma
11 Patients Enrolled for Glioblastoma

Media Library

Glioblastoma Research Study Groups: NanO2TM, Placebo
Glioblastoma Clinical Trial 2023: NanO2TM Highlights & Side Effects. Trial Name: NCT03862430 — Phase 2
NanO2TM (Oxygen Enhancer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03862430 — Phase 2
~30 spots leftby Jun 2025
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