A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma
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.
• 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) prior to study entry, for the duration of study participation, and for 7 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• \- Has not undergone a hysterectomy or bilateral oophorectomy; or
• \- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• 7\. Ability to understand and the willingness to sign a written informed consent.