A Prospective, Open-label Phase 0 Single-center Study to Assess the Effect of Acetadote on Metabolism in Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Acetadote 150 mg/kg IV
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.
干预措施: Acetadote (Drug)
结局指标
主要结局
To determine the effect of Acetadote on glioblastoma metabolism as measured by MRS.
时间窗: Day 1 and up to 21 days from Day 1
The effect of Acetadote on glioblastoma metabolism will be assessed by measuring cysteine, glutathione, and lactate in glioblastoma through MRS.
次要结局
- 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)
研究者
Evan Noch
ASSISTANT PROFESSOR, Neurology
University of Texas Southwestern Medical Center