Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.
研究概览
简要总结
The aim of this study is to determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using Vascular Targeted Photodynamic therapy in obstructive Non-Small Cell Lung Cancer.
详细描述
This study is designed as a multicentre, exploratory phase IIa, open label, single intravenous (IV) dose, escalating treatment regimen (Treatment regimen = a single dose of WST11 associated with a particular laser light energy) with a one month follow-up.
Six escalating treatment regimens will be followed: 3 WST11 doses (5 mg/kg; 7.5 mg/kg and 10 mg/kg) combined with 2 light energies (200 Joules/cm and 300 Joules/cm)
The patient will be treated under local anesthesia. The light is produced using a specific laser at a wavelength of 753 nm at a fixed power of 250 mW/cm and locally delivered to the obstructing tumor through an optical fiber placed, during endoscopy, in the endoscope operating channel with visual control, possibly video-transmission assisted. The fiber illuminating diffusion length is fixed (2 cm).
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
- •Histologically proven lung cancer
- •Inoperable
- •Non-Small Cell Cancer
- •Partial or total bronchial obstruction responsible for functional signs
- •T1 to T4, N0-N3, M0-M1
- •Patients with functional signs: hemoptysis, infection, cough and, above all, dyspnea
- •Contralateral metastases not representing a contraindication insofar as they do not represent a risk of impairment of respiratory function during treatment
- •The Karnofsky index should be greater than or equal to 40
- •Patients should agree to and tolerate repeated bronchial endoscopy (a disadvantage of all endoscopic treatments)
- •Male or female patients aged over 18 years, female patients should not be pregnant (menopause or contraception)
- •Patients should have given their written consent to take part in the study
排除标准
- •Tracheal lesions and lesions affecting the carina tracheae
- •Patients with painful bone metastases (not an absolute criterion since the extent of dyspnea is the decisive element)
- •Patients with brain metastases
- •Patients having undergone pneumonectomy
- •Patients undergoing chemotherapy or radiotherapy or having undergone chemotherapy less than 4 weeks before the procedure or radiotherapy less than 4 weeks before the procedure
- •Patients with risk of large vessel erosion or perforation resulting from lesion topography
- •In case of allergy to the photosensitizer
- •Leukopenia (WBC<2000), Thrombocytopenia (< 100 000), PT > 1.5 normal, Fibrinogen < 2g/l, a PTT > 1.5 ULN (Upper Limit of Normal)
- •Renal insufficiency
- •Hepatic insufficiency
- •Patients having already received 70 Gy on the lesion
- •Existing tracheoesophageal or bronchoesophageal fistula
- •Emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion
研究组 & 干预措施
WST11
Treatment with WST11-mediated VTP
干预措施: WST11 (Drug)
结局指标
主要结局
The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.
时间窗: Week 1, Month 1
次要结局
- Quality of life will be assessed through the validated patient questionnaires(Baseline, Week 1, Month 1 & Month 3)
- The evaluation of safety will be based on adverse events reporting throughout the duration of the study, on the monitoring of vital signs and ECGs, on laboratory tests,clinical examination and chest X Ray.(Screening-Month 3)
- To assess pharmacokinetic parameters of WST11(Day 1)