Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Occurrence of serious adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of I-PDT with Temoporfin for patients with Non-Resectable Non-Small-Cell Lung Cancer (NR-NSCLC). Several clinical studies suggested that photodynamic therapy (PDT) may be an effective treatment for patients with NR-NSCLC. PDT is a therapy where an external light source, such as laser, is used to activate a light-sensitive medicine to produce byproducts that can destroy cancer cells. In this study the investigators will use an experimental light sensitive medicine, Temoporfin, to perform interstitial PDT (I-PDT). In I-PDT, laser fibers are inserted into the tumor to activate the light-sensitive medicine.
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
- •Eighteen years of age and older, male or female, of all races and ethnicities.
- •Histologically confirmed non-small-cell lung cancer (NSCLC).
- •Not a candidate for curative surgery.
- •Not a candidate for curative concurrent chemoradiation therapy.
- •Not a candidate or does not wish to receive curative radiation therapy.
- •Not a candidate or does not wish to receive radiofrequency or microwave thermal ablation.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status <
- •The tumor is observable in CT with contrast.
- •The tumor is accessible for unrestricted illumination of interstitial photodynamic therapy (I-PDT).
- •Deemed likely to survive for at least 3 months.
- •Patient is able and willing to provide written informed consent to participate in the study.
- •If the subject is a female of childbearing potential, the subject is willing to take a pregnancy test and practice strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after Temoporfin administration. Women who have had a hysterectomy are exempt from these requirements.
- •Subject is willing to remain in a controlled light exposure environment for a time period of at least 15 days.
- •History of laboratory tests that meet the following criteria
- •Hematocrit >= 33%, hemoglobin >= 11 g/dl
- •Platelet count > 70,000 per microliter
- •White blood count > 3,000 per microliter or ANC > 1500 per microliter
- •Creatinine: 0.8 to 1.4 mg/dL
- •Serum chloride: 101 to 111 mmol/L
- •Serum potassium: 3.7 to 5.2 mEq/L
- •Serum sodium: 136 to 144 mEq/L
- •Liver function test: albumin, bilirubin (direct/conjugated), ALT (alanine transaminase), AST (aspartate transaminade), GGT (gamma glutamyl transferase), ALP (alkaline phosphatase) within normal limits
- •BUN: 7 to 20 mg/dL
排除标准
- •The tumor invades a major blood vessel.
- •The tumor is not clearly shown on the CT image.
- •The tumor size is larger than 5 cm when measured in a contrasted CT image according to RECIST v1.
- •The location and extension of the tumor precludes an effective I-PDT.
- •Patient with porphyria or other diseases exacerbated by light.
- •Patient with hypersensitivity to Temoporfin or to any of its excipients.
- •Patient with known allergies/hypersensitivity to porphyrins.
- •Patient with a planned surgical procedure within the next 30 days.
- •Patient with a coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days.
- •Patient with existing therapy with a photosensitizing agent (Temoporfin, porphyrin or derivatives of porphyrin).
- •Patient has received prior PDT to the proposed treatment site within the prior 3 months.
- •Patient with known sensitivity to the CT contrast agent (Omnipaque), which would preclude the use of the CT contrast agent.
- •History of poor renal function as demonstrated by serum creatinine and estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m2, which would preclude the using of the CT contrast agent.
结局指标
主要结局
Occurrence of serious adverse events
时间窗: 14 and 30 days post-therapy
The specific aim of this pilot study is to evaluate the safety of CT-guided I-PDT with Temoporfin on patients with NR-NSCLC. Patient safety will be the primary endpoint. The safety of the intervention will be assessed at 14 and 30 days post-therapy. The primary outcome will be occurrence of Serious Adverse Events (SAE).
次要结局
未报告次要终点