A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma
University of Texas Southwestern Medical Center
Summary
This goal of this clinical trial is to evaluate how Acetadote affects metabolism in patients with glioblastoma. Drugs like Acetadote, which affect the level of damage in a cell (oxidative stress), may impact brain tumor metabolism and slow the growth of brain tumors. The investigators are evaluating how Acetadote affects glioblastoma metabolism by using MRI-based methods and by determining the changes in metabolism in brain tumor tissue resected from patients with a new diagnosis of glioblastoma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 1\. Glioblastoma * 2\. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent * 3\. Age ≥18 years * 4\. KPS \> 70 * 5\. Adequate organ and marrow function as defined below: * \- Bilirubin ≤1.5 times upper limit of normal * \- AST and ALT ≤ 3 times ULN * \- Creatinine ≤ 1.5 x ULN and/or GFR ≤ 60 mL/min * -ANC ≥ 1000 cells/ul * \- Platelet ≥ 100,000/ul * \- Hemoglobin ≥ 9 g/dl * 6\. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) pr…
Interventions
- DrugAcetadote
Acetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour
Location
- University of Texas Southwestern Medical CenterDallas, Texas