What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, such as radiation therapy combined with temozolomide chemotherapy, often result in several side effects. Radiation therapy can cause fatigue, hair loss, skin changes, and inflammation of the tissues around the treated area. Temozolomide is associated with side effects like nausea, vomiting, loss of appetite, constipation, and an increased risk of infections due to lowered blood cell counts. When these treatments are combined, patients may experience an exacerbation of these side effects, including more pronounced fatigue and gastrointestinal issues.

What prior FDA approvals exist?

One notable FDA-approved treatment for Glioblastoma is Temozolomide, an oral chemotherapy drug that is often used in combination with radiation therapy. Temozolomide works by sensitizing tumor cells to radiation, thereby enhancing the effectiveness of the radiation treatment. Another treatment approach involves the use of Motexafin Gadolinium, which has been studied in combination with stereotactic radiosurgery to improve outcomes in Glioblastoma patients. These treatments share a common goal with NanO2TM, which is to enhance the efficacy of radiation therapy in targeting tumor cells.

What other types of research exist?

Promising novel alternatives to NanO2TM for Glioblastoma patients include: 1) Tumor Treating Fields (TTFields) - a non-invasive treatment that uses electric fields to disrupt cancer cell division. 2) Immunotherapy agents such as checkpoint inhibitors (e.g., pembrolizumab) which enhance the immune system's ability to target cancer cells. 3) Oncolytic viruses, which selectively infect and kill tumor cells while stimulating an anti-tumor immune response. 4) CAR-T cell therapy, which involves modifying a patient's T cells to better recognize and attack cancer cells. These treatments are being actively researched and have shown potential in improving outcomes for GBM patients.

Oxygen Enhancer

NanO2 for Glioblastoma (RESTORE Trial)

Cleveland, OH

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

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.

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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.Check my eligibility

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.See study design

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.

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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.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22 months

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

0 / 16Eligibility criteria met

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.