ACTIVE_NOT_RECRUITING

A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE: RESTORE

Quick Facts

Study Start:2023-03-31

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03862430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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).	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.
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).

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Center for Neurosciences

Tucson, Arizona, 85718

United States

University of Arizona

Tucson, Arizona, 85719

United States

UC Irvine Health- Chao Family Comprehensive Cancer Center

Orange, California, 92868

United States

Providence St. John's Cancer Institute

Santa Monica, California, 90404

United States

Yale Cancer Center

New Haven, Connecticut, 06520

United States

St. Francis Medical Center, OSF Healthcare

Peoria, Illinois, 61637

United States

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121

United States

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111

United States

Atlantic Health System

Summit, New Jersey, 07901

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: NuvOx LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-31

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-03-31

Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma Multiforme