NCT05773326终止早期 1 期
A Phase 0, Single-center, Open-label, Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma
Nader Sanai2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Tumor pharmacokinetics (PK) of temsirolimus
研究概览
简要总结
This is a single-center, open-label, dose-escalating Phase 0 trial that will enroll participants with a confirmed diagnosed recurrent high-grade glioma (grade 3 or 4 per WHO criteria) targeting the mTOR pathway. Eligible participants will be administered a single infusion of temsirolimus through super-selective intra-arterial infusion or intravenous infusion. Participants will receive the study drug administration on the same day as the planned surgical resection of the tumor.
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
- •Histologically diagnosed high-grade glioma (Grade 3 or 4 per 2021 WHO criteria) in the frontal lobe.
- •Tissue must demonstrate mTOR+: PTEN loss OR PIK3C2B or AKT3 amplification on aCGH OR mutations for PIK3CA or PIK3R1, or mTOR or PTEN mutations using next-generation sequencing analysis OR pS6 positivity on immunohistochemistry (≥30% for pS6).
- •Patients who have completed the Stupp regimen.
- •Have measurable disease pre-operatively, defined as at least 1 contrast enhancing lesion, with 2 perpendicular measurements of at least 1 cm, as per RANO criteria.
- •Sufficient biopsy or archival tissue to confirm eligibility
- •Has voluntarily agreed to participate by giving written informed consent. Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
- •Age ≥18 at time of consent.
- •Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale
- •Participant has adequate bone marrow and organ function
- •Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.
- •For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation until the end of treatment administration and for 3 months after the last dose of study drug.
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner until the end of treatment administration and for 3 months after the last dose of study drug.
- •Agreement to adhere to Lifestyle Considerations throughout study duration
排除标准
- •Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- •Pregnancy or lactation.
- •Known hypersensitivity to temsirolimus or its metabolites, polysorbate 80, or to any other component of temsirolimus.
- •Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, active infection, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance]
- •Received a live vaccination or is in close contact with someone who received a live vaccination within 28 days of the start of study treatment
- •Treatment with another investigational drug or other intervention within 30 days prior to the planned treatment Day 1.
研究组 & 干预措施
Single infusion of Temsirolimus
Experimental
Single infusion of Temsirolimus via super-selective intra-arterial infusion or IV
干预措施: Temsirolimus (Drug)
结局指标
主要结局
Tumor pharmacokinetics (PK) of temsirolimus
时间窗: Day 1 (Intraoperative)
Total and unbound temsirolimus concentration in tumor tissue.
次要结局
- Pharmacodynamic effects of temsirolimus(Day 1 (Intraoperative))
研究者
Nader Sanai
Director of the Ivy Brain Tumor Center
St. Joseph's Hospital and Medical Center, Phoenix
研究点 (2)
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