A Phase 2 Trial of Pharmacological Ascorbate With Concurrent Chemotherapy and Radiation Therapy for Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progression Rate at the Completion of Radiation and Chemotherapy
研究概览
简要总结
This clinical trial evaluates adding high-dose ascorbate (vitamin C) to a standard therapy for non-small cell lung cancer. The standard therapy is radiation therapy combined with carboplatin and paclitaxel (types of chemotherapy). All subjects will receive high-dose ascorbate in addition to the standard therapy.
详细描述
For selected stages of non-small cell lung cancer (NSCLC), standard treatment involves radiation therapy and chemotherapy. The chemotherapy regimen typically used is paclitaxel and carboplatin. Both of these chemotherapeutic drugs are administered intravenously, using a vein in the arm. Radiation is administered using a machine external to the body (usually a linear accelerator). After combined therapy, NSCLC patients receive 2 extra cycles of chemotherapy, called "consolidation chemotherapy."
This study adds 75 grams of ascorbate (vitamin C, sometimes called pharmacological ascorbate because the dose is so high) at specific timepoints in the therapy. The ascorbate is administered intravenously - through a vein in your arm.
Participants will:
- receive 75 grams of intravenous ascorbate 3 times per calendar week while they are receiving radiation therapy. The IV will be running while the radiation therapy is administered.
- undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays.
- provide blood samples to determine the biological effects, if any, the ascorbate has on the body during therapy
This active therapy portion lasts for about 10 to 12 weeks. After that is done, participants go back to standard follow-up for their cancer and any additional therapy their doctors believe they need.
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
- •Note: patients who have a small pleural effusion that is too small to safety tap and is not visible on a chest x-ray are still eligible
- •Pathologic diagnosis (i.e., cell sample, biopsy, tissue swap, bronchoscopy) of non-small cell lung cancer.
- •Recommended to receive carboplatin & paclitaxel with radiation therapy as a treatment
- •Tumor or metastatic disease must measure at least 1 cm using a CT scan (CAT scan)
- •Physician determined the patient is healthy enough for chemotherapy and radiation therapy
- •At least part of the lung cancer must be viewable and measurable by CT or MRI
- •A platelet count of at least 100,000 cells per mililiter
- •A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min*1.73m2)
- •Not pregnant, and commit to using birth control during the study
排除标准
- •Exudative pleural effusion
- •Recurrent non-small cell lung cancer
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Patients actively receiving insulin or patients whose doctors have recommended current insulin use
- •Patients requiring daily finger-stick blood glucose measurements
- •Patients who are on the following drugs and cannot have a substitution or who decline the substitution:
- •flecainide
- •methadone
- •amphetamines
- •quinidine
- •chlorpropamide
- •Prior radiation therapy that would result in a field overlap
- •Enrolled in another therapeutic clinical trial
- •Uncontrolled, intercurrent illness
- •Lactating women
- •HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy
- •If all the above are met, the potential participant will receive a 15 gram challenge dose of ascorbate via intravenous infusion. This is the final screening procedure.
研究组 & 干预措施
ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
干预措施: Carboplatin (Drug)
ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
干预措施: Ascorbic Acid (Drug)
ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
干预措施: Radiation Therapy (Drug)
ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression Rate at the Completion of Radiation and Chemotherapy
时间窗: 3 to 4 weeks after last radiation treatment
The proportion of participants with progressive disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at the completion of radiation and chemotherapy.
次要结局
- Tumor Response(Every six months for up to 20 years post-treatment)
- Progression Free Survival (PFS)(Every six months for up to 20 years post-treatment)
- Overall Survival (OS)(Every three months for up to 20 years post-treatment)
- Adverse Event Frequency and Categorization(Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment)
研究者
Bryan Allen
Assistant Professor, Department of Radiation Oncology
University of Iowa