Imaging Acetadote Metabolism in Glioblastoma

NCT07387666 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STU20250529; SCCC-07325
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma; GBM

Outcome Measures

Primary Outcomes (1)

• To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS.

  The effect of Acetadote on glioblastoma metabolism will be assessed by measuring cysteine, glutathione, and lactate in glioblastoma through MRS.

  Day 1 and up to 21 days from Day 1

Secondary Outcomes (1)

• To determine the effect of Acetadote on glioblastoma metabolism in resected tumor tissue as measured by LCMS

  Day 1 and up to 21 days from Day 1

Study Arms (1)

Acetadote 150 mg/kg IV

EXPERIMENTAL

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.

Drug: Acetadote

Interventions

Acetadote DRUG

Acetadote 150 mg/kg in 500 cc 5% dextrose IV over 1 hour

Acetadote 150 mg/kg IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Glioblastoma
• \. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent
• \. Age ≥18 years
• \. KPS \> 70
• \. 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
• \. 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. 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cumberland Pharmaceuticals: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Omar Raslan, MBBCH, MPH, CCRP

CONTACT

214-648-7097; omar.raslan@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR, Neurology

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)