Phase 2 Study of NanO2 Combined with Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

Sponsor: NuvOx LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03862430

Provider View

This clinical trial is testing a new treatment called NanO2, which is given with standard radiation and chemotherapy to see if it can help deliver more oxygen to brain tumors, potentially making radiation therapy more effective.

Patient Parameters

Program Overview

The study is exploring whether adding NanO2, a treatment designed to increase oxygen delivery to tumors, can improve the effectiveness of standard radiation and chemotherapy in patients with newly diagnosed glioblastoma multiforme (GBM). Participants will receive either NanO2 or a placebo infusion before their radiation therapy sessions.

Description

Participants in this study will receive the usual treatment for glioblastoma, which includes the chemotherapy drug Temozolomide and radiation therapy. They will be randomly assigned to receive either NanO2 infusions or a placebo (saline) infusion before their radiation therapy. Radiation therapy will be given five days a week for six weeks. After completing radiation, there will be a 28-day recovery period, followed by six cycles of maintenance Temozolomide therapy, which involves taking the drug for five days every 28 days. Participants will have follow-up visits every three months for the first three years, and then every six months for the next two years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of newly diagnosed glioblastoma multiforme (GBM).
  • Treatment plan includes receiving 60 Gy of radiation in 30 sessions, along with Temozolomide chemotherapy.
  • Must be 18 years or older.
  • Must have a Karnofsky Performance Status score of 70 or higher, indicating the ability to care for oneself.
  • Must have a life expectancy of at least three months.
  • Must be able to undergo MRI scans with gadolinium contrast.
  • Must have adequate blood, kidney, and liver function as shown by specific lab tests.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use effective birth control during the study and for four months after completing treatment.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have recurrent glioblastoma or have had prior treatment for glioblastoma other than surgery.
  • Have multiple glioblastoma tumors that cannot be safely treated with radiation.
  • Have bleeding in the brain, except for stable minor bleeding or post-surgery bleeding that is improving.
  • Have not fully recovered from surgery, except for ongoing neurological issues.
  • Have had a stroke or heart attack within six months before joining the study.
  • Have severe heart or lung conditions, uncontrolled high blood pressure, or other serious health issues.
  • Have active infections or a history of other cancers, except for certain skin cancers or cancers treated successfully over two years ago.
  • Are pregnant or breastfeeding.
  • Are unable to follow study procedures or have allergies to study medications.

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