Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Hypoxia

Glioma

Brain Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Channel Blockers

Anticonvulsants

All Drugs and Chemicals

Antineoplastic Agents

Phenytoin

Trans-sodium crocetinate

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Protective Agents

0.5 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none

0.75 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none

1.0 mg/kg TSC, anticonvulsants at Baseline - phenytoin only or none

Dose of TSC either 0.5 mg/kg, 0.75 mg/kg, or 1.0 mg/kg based on the Data Monitoring Committee decision, anticonvulsants at Baseline - phenytoin only or none

0.5 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none

0.75 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none

1.0 mg/kg TSC, anticonvulsants at Baseline - any except phenytoin-only or none

Dose of TSC either 0.5 mg/kg, 0.75 mg/kg, or 1.0 mg/kg based on the Data Monitoring Committee decision, anticonvulsants at Baseline - any except phenytoin-only or none

Single bolus intravenous administration in a superficial vein of the arm over a period of up to 2 minutes.

Trans Sodium Crocetinate (TSC)

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.

Trans Sodium Crocetinate (TSC) Study of Intra-tumoral Oxygen Concentration, Safety, and Pharmacokinetics in Patients With High Grade Glioma

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trans Sodium Crocetinate (TSC) Study of Intra-tumoral Oxygen Concentration, Safety, and Pharmacokinetics in Patients With High Grade Glioma	NCT00826930	High Grade Glio...	Trans Sodium Cr...	18 Years -	Diffusion Pharmaceuticals Inc
Trans Sodium Crocetinate (TSC) Study of Intra-tumoral Oxygen Concentration, Safety, and Pharmacokinetics in Patients With High Grade Glioma	NCT00826930	High Grade Glio...	Trans Sodium Cr...	18 Years -	Diffusion Pharmaceuticals Inc

Spots Global Cancer Trial Database for tumor tissue hypoxia