A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloroacetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Safety and tolerability of DCA in combination with radiotherapy and temozolomide in an adjuvant setting for the treatment of newly diagnosed GBM patients.
研究概览
简要总结
This is a study to see whether radiotherapy plus chemotherapy (Temozolomide) plus Dichloroacetate (DCA) improves overall survival and offers better control of the disease in patients with newly diagnosed Glioblastoma Multiforme Tumours.
详细描述
Patients with newly diagnosed Glioblastoma Multiforme Tumours, once consented to the study, would undergo standard treatment of radiotherapy plus chemotherapy (TMZ) with DCA in pill form (twice a day) during the radiation phase of the study and then with TMZ for six months after. Other elements of the clinical trial include pharmacokinetics and MGMT genetic testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •newly diagnosed GBM
- •Diagnosis must be established by open biopsy or tumour resection
- •Tumour must have a supratentorial component
- •Over 18 years
- •pre-treatment evaluations must be met
- •study therapy to begin within 6 weeks of surgery
- •KPS greater or equal to 70
- •patients must sign informed consent
- •If female, patients must not be pregnant or lactating
- •Women of childbearing potential and male participants must practice adequate contraception
排除标准
- •prior invasive malignancy )except for non-melanomatous skin cancer) unless disease free for greater than 3 years
- •recurrent or multifocal malignant gliomas
- •metastatic disease of leptomeningeal spread
- •prior chemo or radiosensitizers for cancers of the head and neck region
- •prior RT to head and neck region except for T1 glottic cancer, resulting in overlap of radiation fields.
- •Severe active co-morbidity define in protocol
- •Pregnant of lactating women
- •Women of childbearing potential or men who are sexually active who are not willing or able to use medically acceptable forms of contraception; this exclusion is necessary due to the treatment involved potentially being teratogenic.
- •prior allergic reaction to temozolomide and/or dichloroacetate
- •History of HIV/AIDS
结局指标
主要结局
Safety and tolerability of DCA in combination with radiotherapy and temozolomide in an adjuvant setting for the treatment of newly diagnosed GBM patients.
时间窗: 2 years
次要结局
- To determine if there is a correlation between MGMT promoter methylation status and progression-free survival for newly diagnosed GBM patients undergoing concurrent TMZ, DCA and RT followed by six monthly cycles of TMZ and DCA(2 years)