Open-label Study to Determine the Effect of Trans Sodium Crocetinate (TSC) on Intra-tumoral Oxygen Concentration, Tolerability, and Pharmacokinetics of TSC in Post-operative Patients With High Grade Glioma (HGG)
- At least 18 years old.
- Prior histological diagnosis of high grade glioma (HGG) with prior initial treatment
and radiation therapy for HGG; recurrence of HGG suspected, and care plan includes
- Undergoing surgical procedure for clinical reasons, and gross surgical resection not
- Neurosurgeon is planning stereotactic biopsy or tumor debulking for clinical reasons;
frozen tissue confirmation of malignancy during this operative procedure is
- Neurosurgeon evaluates that placement of oxygen monitoring probe after biopsy or
debulking can be done safely without complications.
- Contrast enhancing disease on MRI within 21 days prior to enrollment.
- Karnofsky Performance Score ≥ 60 at Screening.
- Recovered from toxicity of prior antineoplastic therapy, and off cytotoxic
chemotherapy for 7 days prior to Screening.
- Recovered from prior radiotherapy and had at least 21 days elapse since completion of
radiotherapy prior to Screening.
- Recovered from prior surgery for their brain tumor in investigator's clinical
- If female, negative serum or urine pregnancy test at Screening.
- Within 2 weeks of starting study, hematologic and renal functions as specified:
Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9.0g/dL,
creatinine ≤ 1.7mg/dl, serum bilirubin ≤ 1.5mg/dL, blood urea nitrogen within 2 times
the upper limit of normal, transaminases ≤ 4 times above the upper limits of the
institutional norm, and prothrombin time and partial thromboplastin time within
institutional norm or below.
- Patient or patient's medical power of attorney provided written consent to
participate in the study.
- Mini Mental Status Exam score ≥ 15.
- Pregnant or lactating.
- Receiving concurrent cytotoxic chemotherapy for their tumor within 7 days prior to
Screening, or decision is made at the time of surgery to treat with other modality of
treatment (e.g., gliadel wafers).
- Serious concurrent infection or medical illness which would jeopardize the ability of
the patient to safely participate.
- Behavioral, cognitive, or psychiatric disease or personal situation that might
interfere with optimal participation.
- Cannot undergo an MRI.
- Received an investigational drug not approved for human use by the FDA within 30 days
- Previously received TSC.