The purpose of this study is to evaluate the impact of Trans Sodium Crocetinate (TSC) on oxygen levels in brain tumor tissue in patients with high grade glioma. The proposed clinical indication for TSC is a radiation sensitizer for the treatment of cancerous tumors.
In this open-label, one-site study, up to 48 patients with high grade glioma (HGG) who are undergoing biopsy or partial debulking of the tumor as part of standard of care will have an oxygen monitoring probe placed in residual tumor tissue. Oxygen levels in the tumor tissue will be measured prior to and after administering a single bolus injection of TSC. Safety assessments will occur throughout the trial, including at a 7 to 14 day follow-up visit. Pharmacokinetic assessments will be performed prior to and during the first 24 hours after TSC dosing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
1
Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.
Johns Hopkins Medical Institute/Johns Hopkins Hospital
Baltimore, Maryland, United States
Change from baseline in tumor tissue oxygen monitoring recordings
Time frame: Daily while inpatient
Safety assessments (laboratory tests)
Time frame: Daily while inpatient, 7-14 Day Follow-up
Pharmacokinetic assessments
Time frame: Day 1, Day 2
Tumor hypoxia biomarkers (HIF 1-alpha, osteopontin, carbonic anhydrase IX)
Time frame: Daily while inpatient
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