Endobronchial Ultrasound Transbronchial Needle Guided Interstitial Photodynamic Therapy for Palliation of Locally Advanced Lung Cancer and Advanced Cancers Obstructing the Airway -Phase I/II
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
研究概览
简要总结
This Phase I/Il studies the side effects of endobronchial ultrasound guided interstitial photodynamic therapy work in treating patients with lung cancer that has spread to nearby tissues or lymph nodes. Photodynamic therapy consists of injecting a light sensitive drug called a photosensitizer, such as porfimer sodium, into the vein, waiting for it to accumulate in the tumor, and then activating it with a red laser light. Giving photodynamic therapy with Porfimer sodium may reduce the tumor size in patients with lung cancer.
详细描述
PRIMARY OBJECTIVES PHASE 1:
I. To evaluate the safety and potential efficacy of endobronchial ultrasound with transbronchial needle (EBUS-TBN) guided interstitial photodynamic therapy (EBUS-TBN I-PDT) and/or I-PDT and/or photodynamic therapy (PDT) in patients with malignant airway obstructions using porfimer sodium as a photosensitizer.
PRIMARY OBJECTIVE Phase II
- I. To assess the tumor response to treatment.
- II To observe changes in well being
SECONDARY OBJECTIVES:
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
- •> 18 year olds
- •Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention
- •For patients in Cohort B only. Patients are amenable to receive a palliative radiotherapy of 8 Gy x1 48±4 h prior to the I-PDT, as determined by the radiation oncologist
- •Patients with an established pathologic diagnosis of small cell and/or non-small cell lung cancer or other malignancies causing airway obstruction > 25% requiring bronchoscopic intervention. Or inoperable malignancies not candidates for curative radiotherapy within the airway.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
- •Platelets >= 100,000 cells/mm^3 (International System of Units [SI] units 100 x 10^9/L).
- •Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •Participant 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
- •Participants who have had radiotherapy to the target tumor within 4 weeks prior to the scheduled I-PDT and/or PDT.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or nursing female participants.
- •Co-existing ophthalmic disease likely to require slit-lamp examination within 14 days following I-PDT and/or PDT treatment.
- •Known hypersensitivity/allergy to porphyrin.
- •Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia.
- •Patients with target tumor invading into the lumen of the esophagus, confirmed by esophago-gastro-duodenoscopy (EGD) with endoscopic ultrasound
- •Patients diagnosed with porphyria.
- •Unwilling or unable to follow protocol requirements.
- •Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive I-PDT or PDT.
研究组 & 干预措施
Treatment (porfimer sodium, EBUS, and photodynamic therapy)
Treatment (porfimer sodium, EBUS, and photodynamic therapy) Patients receive 2 mg/kg porfimer sodium IV over 3-5 minutes 48 +/- 4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over few hours.
干预措施: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy (Procedure)
Treatment (porfimer sodium, EBUS, and photodynamic therapy)
Treatment (porfimer sodium, EBUS, and photodynamic therapy) Patients receive 2 mg/kg porfimer sodium IV over 3-5 minutes 48 +/- 4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over few hours.
干预措施: Porfimer Sodium (Drug)
结局指标
主要结局
Number of Participants With Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
时间窗: Up to 4 weeks
Number of Participants with Adverse Events That Are \>= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Number of Participants With Tumor Response
时间窗: up to 24 weeks
Will be reported using frequencies
次要结局
- Progression-free Survival (PFS) Assessed Using Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria(From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks)