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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)

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ClinicalTrials.gov Identifier: NCT03862430
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
NuvOx LLC

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: NanO2TM Drug: Placebo Saline Infusion Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 31, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NanO2TM
NanO2TM infusion in conjunction with Radiation Treatment and temozolomide
 Drug: NanO2TM
0.1 mL/kg NanO2 infusion
Other Name: Dodecafluoropentane emulsion (DDFPe)
Placebo Comparator: Placebo
Placebo Saline infusion in conjunction with Radiation Treatment and temozolomide
 Drug: Placebo Saline Infusion
Saline Infusion
Other Name: 0.9N NaCl


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 22 months ]
    To determine progression free survival (PFS) in newly-diagnosed glioblastoma patients after treatment with NVX-108 in combination with radiation and temozolomide (TMZ)


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 22 Months ]
    To determine overall survival (OS) in newly-diagnosed glioblastoma patients after treatment with NanO2TM at the RD in combination with radiation and temozolomide.Neuro-oncology (RANO) criteria

  2. Response assessment by mRANO [ Time Frame: 22 Months ]
    To determine the objective response rate to study therapy using the modified Response Assessment in Neuro-oncology (mRANO) criteria

  3. Response assessment for pseudoprogression [ Time Frame: 22 Months ]
    To determine the effect of NanO2 on the timing of pseudoprogression occurrence

  4. To confirm that NanO2 re-oxygenation [ Time Frame: 22 Months ]
    Via TOLD MRI, we measure the oxygenation level in tumor tissue, to confirmd NanO2 treatment causes the re-oxygenation of hypoxic tissue

  5. To estimate the effect on the duration of functional independence [ Time Frame: 22 Months ]
    To estimate the effect on the duration of functional independence, as measured by the periodic measurement of Karnofsky Performance Scale

  6. Patient quality of life [ Time Frame: 22 Months ]
    To measure NanO2 treatment's impact on patient quality of life (score) by using FACT-Br

  7. Caregiver quality of life [ Time Frame: 22 Months ]
    To measure NanO2 treatment's impact on caregiver quality of life (score) by using questionnaires form CQOLC


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862430


Contacts
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Contact: Evan Unger, MD 520-624-6688 eunger@nuvoxpharma.com
Contact: Rong Wang, MBA 520-624-6688 rwang@nuvoxpharma.com

Locations
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United States, Arizona
Center for Neurosciences Recruiting
Tucson, Arizona, United States, 85718
Contact: Christina Diaz    520-320-2157    cdiaz@neurotucson.com   
University of Arizona Recruiting
Tucson, Arizona, United States, 85719
Contact: Baldassarre Stea, MD, PhD    520-694-2347      
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Neydin Osorio    504-703-5577    neydin.tejeda@ochsner.org   
United States, New Jersey
Atlantic Health System Recruiting
Summit, New Jersey, United States, 07901
Contact: Molly Whelan    908-522-5053    neuroscienceresearch@atlantichealth.org   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Central Team    919-684-5301    dukebrain1@dm.duke.edu   
Sponsors and Collaborators
NuvOx LLC
More Information
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Responsible Party: NuvOx LLC
ClinicalTrials.gov Identifier: NCT03862430    
Other Study ID Numbers: RESTORE-P2
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue