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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)

Phase 1
18 Years
Not Enrolling
High Grade Glioma

Thank you

Trial Information

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)

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.

Inclusion Criteria:

- 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
surgical procedure.

- 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.

Exclusion Criteria:

- 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
of enrollment.

- Previously received TSC.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Change from baseline in tumor tissue oxygen monitoring recordings

Outcome Time Frame:

Daily while inpatient

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

May 2009

Related Keywords:

  • High Grade Glioma
  • High Grade Glioma
  • Brain Tumor
  • Solid Tumor
  • Partial Debulking
  • Tumor Resection
  • Tumor Tissue Hypoxia
  • Radiation Sensitizer
  • Cancerous Tumor
  • Glioma



Johns Hopkins Medical Institute/Johns Hopkins HospitalBaltimore, Maryland  21205