A Multicenter, Prospective, Open-label, Non-randomized Single-arm Clinical Study of the Safety and Tissue Response to Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Solid Lung Tumor Prior to Surgical Resection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Safety: Number of Participants With at Least One Adverse Event
研究概览
简要总结
This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.
详细描述
Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy) have been shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location.
Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lightning the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube with a light, called bronchoscope for the lung. The light activates the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.
The purpose of this study is to assess the safety of using photodynamic therapy prior to surgical resection of tumors located in the periphery of the lung.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-79
- •Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung that can be completely resectable
- •Candidate for surgical resection
- •Candidate for bronchoscopy
- •Tumor is accessible for unrestricted illumination of PDT
- •Subject is deemed likely to survive for at least 3 months
- •Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry
- •Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control
- •Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines & local requirements
排除标准
- •Diagnosis of small cell lung cancer or carcinoid tumors
- •Primary or metastatic lung tumor located in central lung or near vertebral body
- •Tumor invades a major blood vessel
- •Presence of concurrent non-solid malignancy
- •Tumor previously treated with radiation therapy
- •Chemotherapy in the last four weeks
- •Tumor treated with PDT within the last 3 months
- •Abnormal blood results
- •Subject with porphyria or hypersensitivity to Photofrin
- •Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days
- •Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures
- •female who is breast-feeding or intends to breast-feed during study
- •subject who participated in another study within last 30 days or intends to participate in another study during this study
研究组 & 干预措施
Photodynamic therapy-Photofrin
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
干预措施: Porfimer Sodium (Drug)
Photodynamic therapy-Photofrin
Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.
干预措施: Fiber optic (Device)
结局指标
主要结局
Safety: Number of Participants With at Least One Adverse Event
时间窗: 108 days (to 3 months post surgery)
Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
时间窗: 108 days (to 3 months post surgery)
Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Safety: Vital Sign Summary of Abnormal Findings for Each Subject
时间窗: 108 days (to 3 months post surgery)
Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
时间窗: 108 days (to 3 months post surgery)
Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
时间窗: 108 days (to 3 months post surgery)
Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
次要结局
- Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery(Day 13 to 18)
- Macroscopic Tissue Examination(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery(Day 13 to 18)
- Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery(Day 13 to 18)
- Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery(Day 13 to 18)
- ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline(Baseline (-30 to -1 Days))
- ECOG Performance Status: Period 1 PDT Day 3(Day 3)
- ECOG Performance Status: Period II Surgery (Day 13-18)(Day 13 to 18)
- ECOG Performance Status: Period III Follow-up (Day 20-25)(Day 20 to 25)
- ECOG Performance Status: Period III Follow-up (Day 43 -48)(Day 43 to 48)
- ECOG Performance Status: Period III Follow-up (Day 103 - 108)(108 days (to 3 months post surgery))