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)

Diffusion Pharmaceuticals Inc1 个研究点分布在 1 个国家目标入组 1 人开始时间: 2009年3月最近更新: 2010年8月12日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Diffusion Pharmaceuticals Inc
入组人数: 1
试验地点: 1
主要终点: Change from baseline in tumor tissue oxygen monitoring recordings

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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 expected.
•Neurosurgeon is planning stereotactic biopsy or tumor debulking for clinical reasons; frozen tissue confirmation of malignancy during this operative procedure is necessary.
•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 judgment.
•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.

排除标准

•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.