Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants That Experience Serious Adverse Events.
研究概览
简要总结
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with sorafenib versus treatment with sorafenib alone in subjects with metastatic hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to assess overall tumor response rate and evaluate disease progression
详细描述
Intravenous Ascorbic Acid (Vitamin C) is a widely used alternative cancer treatment. This trial will study an intravenous Vitamin C treatment for persons with liver cancer that has spread, who are also receiving Sorafenib (a standard cancer drug), to see whether the combination of Vitamin C and Sorafenib is safe and well tolerated. Phase I will involve 6 persons who will receive the Vitamin C for 8 weeks to more specifically assess the safety of getting Vitamin C in combination with Sorafenib. Phase II will be randomized to receive either Vitamin C plus Sorafenib or Sorafenib alone for 16 weeks. If Vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age > 18 years
- •Metastatic hepatocellular carcinoma
- •G6PD (glucose-6-phosphate dehydrogenase) status > lower limit of normal
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper limit (if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour creatinine clearance will be obtained); transaminase (AST/ALT) ≤2.0X upper limit of normal; bilirubin levels ≥ 2 mg/dL; ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥ 100,000/mm3
- •Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the study.
- •Willing and able to provide informed consent and participate in the study procedures.
排除标准
- •Patients with evidence of a significant current psychiatric disorder that would prevent completion of the study as determined by the PI will not be allowed to participate.
- •Co-morbid medical condition that would affect survival or tolerance as determined by the PI. This includes patients who have not fully recovered from toxicities associated with prior therapy. It also includes subjects who, as determined by the PI, are at risk of experiencing fluid overload (i.e., congestive heart failure).
- •Patients who currently abuse alcohol or drugs.
- •Patients with known glomerular filtration rate of <60ml/min or with nephrotic range proteinuria.
- •Pregnant or lactating women
- •Enrollment in active clinical trial/ experimental therapy or IND study within the prior 30 days.
- •Contraindication for CT or PET/CT as per the PI.
研究组 & 干预措施
Ascorbic Acid + Sorafenib
Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate
Dosage:
Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)
干预措施: Ascorbic Acid + Sorafenib (Drug)
Sorafenib alone
Sorafenib: taken daily (oral)
干预措施: Sorafenib (Drug)
结局指标
主要结局
Number of Participants That Experience Serious Adverse Events.
时间窗: 16 weeks +/- 2 weeks
The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with sorafenib therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE)v4.0
次要结局
- Overall Tumor Response Rate(16 weeks +/- 2 weeks)
- Mean Value Collected Using the Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument(16 weeks +/- 2 weeks)
- Number of Participants That Are Alive After 15 Weeks of Treatment.(15 weeks+)