How Acetadote might affect metabolism in newly diagnosed glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early-phase, interventional study examining the effects of Acetadote on metabolism in glioblastoma. Researchers will use MRI to measure metabolic changes in brain tumor tissue obtained from participants at the time of diagnosis. Eligible patients are adults with newly diagnosed glioblastoma who have not yet had surgery, radiation, or chemotherapy and who meet health criteria. The study is led by UT Southwestern and involves Cumberland Pharmaceuticals. Enrollment is limited to locations at UT Southwestern in Dallas, TX.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Omar Raslan, MBBCH, MPH, CCRP
• Email: omar.raslan@utsouthwestern.edu
• Phone: 214-648-7097

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.