Studying the Effects of Acetadote on Metabolism in Treating Patients with Newly Diagnosed Glioblastoma
This early phase I trial studies how Acetadote affects metabolism in treating patients with newly diagnosed 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.
Inclusion Criteria
- Glioblastoma
- Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent
- Age ≥ 18 years
- Karnofsky performance status (KPS) > 70
- Bilirubin ≤ 1.5 times upper limit of normal
- Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal (ULN)
- Alanine aminotransferase (ALT) ≤ 3 times ULN
- Creatinine ≤ 1.5 x ULN and/or glomerular filtration rate (GFR) ≤ 60 mL/min
- Absolute neutrophil count (ANC) ≥ 1000 cells/ul
- Platelet ≥ 100,000/ul
- Hemoglobin ≥ 9 g/dl
- 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 * 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)
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
- Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment
- Subjects must have recovered from prior treatment-related toxicities to grade 2 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment)
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
- Brain metastases
- History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Acetadote
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07387666.
Locations matching your search criteria
United States
Texas
Dallas
PRIMARY OBJECTIVE:
I. To determine the effect of acetylcysteine (Acetadote) on glioblastoma metabolism as measured by magnetic resonance spectroscopic imaging (MRS).
SECONDARY OBJECTIVE:
I. To determine the effect of Acetadote on glioblastoma metabolism in resected tumor tissue as measured by liquid chromatography mass spectrometry (LCMS).
EXPLORATORY OBJECTIVE:
I. To correlate Acetadote levels in blood and cerebrospinal fluid (CSF) with metabolic effects of Acetadote in glioblastoma.
OUTLINE:
Patients undergo MRS at baseline. Patients then receive acetylcysteine intravenously (IV) over 60 minutes and undergo MRS on day 1. Between days 2-21, patients receive acetylcysteine IV over 60 minutes and undergo surgical resection as soon as acetylcysteine infusion begins in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) during screening as well as blood and CSF sample collection on study.
After completion of study treatment, patients are followed up for 1 month or until death, whichever occurs first.
Trial PhasePhase O
Trial Typetreatment
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorEvan Noch
- Primary IDSCCC-07325; STU20250529
- Secondary IDsNCI-2026-06307
- ClinicalTrials.gov IDNCT07387666