NCT04863950招募中2 期
A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年5月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is at least 18 years of age
- •The subject has the ability to understand the purposes and risks of the study and to have signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- •The subject has histologically confirmed glioblastoma
- •The subject has progression following standard combined modality treatment with radiation and temozolomide chemotherapy
- •The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
- •The subject has a life expectancy of at least 3 months
- •The subject has acceptable liver function:
- •Bilirubin ≤ 1.5 times upper limit of normal
- •AST (aspartate aminotransferase) (SGOT) and ALT (alanine transaminase 0 (SGPT) ≤ 3.0 times upper limit of normal (ULN)
- •The subject has acceptable renal function:
- •Serum creatinine ≤ULN
- •The subject has acceptable hematologic status (without hematologic support):
- •ANC (absolute neutrophil count) ≥1500 cells/uL
- •Platelet count ≥100,000/uL
- •Hemoglobin ≥9.0 g/dL
- •All women of childbearing potential (not surgically sterilized or at least 1 year post-menopausal) must have a negative serum pregnancy test. Additionally, male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.
排除标准
- •The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
- •The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
- •The subject is unable to undergo MRI scan (eg, has pacemaker).
- •The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
- •The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.
- •The subject has evidence of wound dehiscence.
- •The subject is pregnant or breast-feeding.
- •The subject has a history of cardiac disease, including arrhythmia, conduction abnormality, congenital prolonged QT syndrome, myocardial infarction, unstable angina pectoris or congestive heart failure.
- •A prolonged QTc rhythm noted during initial ECG >480 ms.
- •The subject has serious intercurrent illness, such as:
- •Hypertension (two or more blood pressure [BP] readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment
- •Non-healing wound, ulcer, or bone fracture
- •Untreated hypothyroidism
- •Unhealed rectal or peri-rectal abscess
- •Uncontrolled active infection
- •Stroke, or transient ischemic attack within 6 months
- •The subject has received any of the following prior anticancer therapy:
- •Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
- •Non-bevacizumab systemic therapy (including investigational agents and small- molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug
- •Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
- •Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
- •Prior treatment with carmustine wafers
- •Any current psychosis, uncontrolled mood disorder (as assessed by investigator) or suicidal ideation. Additionally, current or history of bipolar disorder is excluded.
- •Patients currently using SSRI, SNRI, MAO inhibitors, tramadol or trazodone who are unwilling to undergo taper.
研究组 & 干预措施
Imipramine Hydrochloride/Lomustine
Experimental
干预措施: Lomustine (Drug)
Imipramine Hydrochloride/Lomustine
Experimental
干预措施: Imipramine Hydrochloride (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 6 months
次要结局
未报告次要终点
研究者
William Kelly
Clinical Investigator
The University of Texas Health Science Center at San Antonio
研究点 (1)
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