Imaging Acetadote Metabolism in Glioblastoma

Официальное название

A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma

Обзор

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.

Вмешательства

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

Первичные конечные точки

• To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS. [Срок оценки: Day 1 and up to 21 days from Day 1]

Вторичные конечные точки (1)

• To determine the effect of Acetadote on glioblastoma metabolism in resected tumor tissue as measured by LCMS [Срок оценки: Day 1 and up to 21 days from Day 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Texas Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT07387666 · STU20250529; SCCC-07325

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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