Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of treatment
研究概览
简要总结
The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can be effective in managing solid tumor diseases. Secondary goals are determination of any palliative effects and improvement of quality of life of patients.
详细描述
Ascorbic acid has demonstrated selective cytotoxicity in cancer cells in vitro, while sparing normal cells from its peroxidative effects. This study will examine the effect, if any, of the drug when dosed in patients at a level sufficient to achieve transient serum states of 400mg/dl. Safety of the drug has been shown in a Phase I study when dosed as high as 1.5gm/kg. Patients will be treated twice weekly for 12 weeks (24-cycles) and evaluated for response using RECIST criteria. Patients showing stable disease or objective response will remain on study for up to one year or until absence of measurable disease or disease progression.
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
- •18 years or older at time of entry on study
- •Disease extent confirmed and documented by CT scan within 45 days of entry on study
- •normal glucose 6-phosphate dehydrogenase
- •no current calcium oxalate nephrolithiasis with the potential to reduce urinary flow
- •ability to understand the informed consent process and to give informed consent to treatment
- •measurable solid tumor neoplastic disease (using RECIST criteria)
- •life expectancy greater than 8-weeks
- •will agree to undergo central line placement (examples are: port-a-catheter, central venous catheter, percutaneously inserted central catheter [PICC] line placement). Patient or regular caregiver must be able to maintain flush central line as directed by study physician. (Study center will provide periodic site dressing changes as required)
- •Failed curative therapy or patient ineligible for definitive curative therapy
- •Karnofsky performance status of at least 40
排除标准
- •any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study
- •use of any nicotine product including nicotine patches/gum
- •unstable angina not well managed with medication
- •history of calcium oxalate stone formation
- •pregnancy or nursing of an infant
- •any psychiatric disorder by history or examination that would prevent completion of the study
研究组 & 干预措施
Intravenous IVC Intervention
Intravenous ascorbic acid, 1.5g/kg at an infusion rate not to exceed 250mg/min.
干预措施: Ascorbic acid (vitamin C) (Drug)
结局指标
主要结局
Efficacy of treatment
时间窗: 12-weeks
Survival as a result of efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by PET/CT scan interpretation, lab studies and current good clinical practice methodologies for solid tumor interventional treatment.
次要结局
- Patient self-assessment of Quality of Life at 12-weeks(12-weeks)