NCT03034135已完成2 期
A Phase II, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of DIsulfiram and Copper Gluconate in Recurrent Glioblastoma
Cantex Pharmaceuticals8 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年3月9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
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.
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 confirmed GBM (WHO grade IV).
- •The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the planned start of treatment on this study UNLESS there is pathological verification of recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent TMZ.
- •Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI) [as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3 months from the last dose of TMZ.
- •Karnofsky performance status (KPS) of at least 60%.
- •Willing to remain abstinent from consuming alcohol.
- •Recovered from the toxic effects of prior therapy to < grade 2 toxicity per NCI CTCAE prior to study registration (except lymphopenia).
- •Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, BUN and creatinine.
- •Females of childbearing potential must be willing to use an acceptable method of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
排除标准
- •Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or disease at sites remote from the supratentorial brain.
- •Enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks.
- •Received more than one course of radiation therapy or more than a total dose of 75 Gy.
- •History of allergic reaction/hypersensitivity to temozolomide, dacarbazine, DSF or Cu.
- •Treatment with the following medications are contraindicated with DSF: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir.
- •Fever within 3 days prior to study enrollment.
- •Active or severe hepatic or renal disease.
- •Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE
- •History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to glioblastoma, corticosteroid, or anti-epileptic medications.
- •History of Wilson's disease.
- •History of hemochromatosis.
- •Pregnant or breastfeeding.
研究组 & 干预措施
DSF-Cu
Experimental
Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.
干预措施: Disulfiram/Copper (Drug)
DSF-Cu
Experimental
Disulfiram/copper (oral capsules) dosed 80 mg/1.5 mg three times a day for approximately 6 months.
干预措施: Temozolomide (TMZ) (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 6 months
ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.
次要结局
- Progression Free Survival(6 months)
- Number of Participants With Serious Adverse Events(14 months)
- Median Duration of Overall Survival(14 months)
- Median Progression Free Survival(12 months)
- Overall Survival(6 months and 12 months)
研究者
研究点 (8)
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