Imaging Acetadote Metabolism in Glioblastoma

The University of Texas System (UT)

Status and phase: Begins enrollment in 4 months; Early Phase 1

Conditions: Glioblastoma; GBM

Treatments: Drug: Acetadote

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07387666

STU20250529 SCCC-07325;

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) 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.

Exclusion criteria

• 1.Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment.
• 2. 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).
• 3. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
• 4. Brain metastases
• 5. History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Acetadote.
• 6. 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.
• 7. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Acetadote 150 mg/kg IV

Experimental group

Description:

Acetadote will be administered twice during this study: first before undergoing magnetic resonance spectroscopy (MRS) on Day 1 and second before undergoing surgical resection, which will take place between Days 2-21. Acetadote will be administered at a dose of 150 mg/kg IV over 60 minutes.

Treatment:

Drug: Acetadote