Body Warming to Alter [Thermo] Regulation and the Microenvironment [B-WARM] Therapy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Changes in tumor vascular (blood flow, blood volume)
研究概览
简要总结
This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility and efficacy of 2 different Body Warming to Alter (Thermo) Regulation and the Microenvironment (B-WARM) regimens on altering tumor blood flow in patients with a variety of malignancies.
SECONDARY OBJECTIVES:
I. To determine if duration and thermal dose of B-WARM changes duration and extent of tumor blood flow changes in patients with a variety of malignancies.
OUTLINE: Patients are randomized to 1of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Patients with a variety of malignancies (i.e., melanoma, sarcoma, colon, head and neck, renal, breast, lung, ovary, liver)
- •Patients must have measurable disease (1.0 cm or greater) by computed tomography (CT) scan
- •Have an estimated glomerular filtration rate (eGFR) (using the Cockcroft-Gault equation) of more than 60 mL/min
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
- •Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •History of prior myocardial infarction or arrhythmia
- •History of any condition deemed by the principal investigator to be a contraindication to B-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc)
- •All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc)
- •Pregnant or nursing female patients
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive B-WARM
- •Received an investigational agent within 30 days prior to enrollment
- •Received any systemic therapy within 21 days prior to planned B-WARM therapy
- •Patients may be enrolled on study but at least 21 days should elapse prior to date of B-WARM therapy
- •Patients should not have either CT scanning or B-WARM if they have a fever at the time
- •Fever should be worked up and treated as appropriate
- •Patients should be afebrile for 24 hours prior to scanning or B-WARM therapy
结局指标
主要结局
Changes in tumor vascular (blood flow, blood volume)
时间窗: Baseline to 24-88 hours
The primary analysis will be implemented using an analysis-of-covariance model for both blood flow and blood volume.
次要结局
- Changes in tumor vascular measures(Baseline to 88-264 hours)
- Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0(Up to 30 days post-treatment)