Utilizing Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC) With Pleural Disease or Malignant Pleural Mesothelioma (MPM) - Phase I Study

Roswell Park Cancer Institute1 个研究点分布在 1 个国家目标入组 5 人2022年3月10日

适应症Lung Non-Small Cell Carcinoma Pleural Disorder

干预措施Porfimer Sodium Video-Assisted Thoracic Surgery Photodynamic Therapy Intraoperative PDT

概览

阶段: 1 期
干预措施: Porfimer Sodium
疾病 / 适应症: Lung Non-Small Cell Carcinoma
发起方: Roswell Park Cancer Institute
入组人数: 5
试验地点: 1
主要终点: Incidence of serious adverse events (SAE)
状态: 终止
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This phase I trial evaluates the side effects of intraoperative photodynamic therapy with porfimer sodium in enhancing the response to immunotherapy with an immune checkpoint inhibitor drug in patients with non-small cell lung cancer with pleural disease. Photodynamic therapy is a technique that that works by combining a photosensitizing agent (porfimer sodium in this trial) and an intense light source to kill tumor cells. Photodynamic therapy may decrease the patients' symptoms and improve their quality of life.

注册库

clinicaltrials.gov

开始日期

2022年3月10日

结束日期

2025年1月3日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Roswell Park Cancer Institute

责任方

Sponsor

入排标准

入选标准

•Histologically confirmed non-small cell lung cancer (NSCLC) with pleural disease and PDL1 expression \< 50% or histologically confirmed diagnosis of malignant pleural mesothelioma not candidates for macroscopic complete resection
•Adequate blood tests 14 days prior to intraoperative PDT and with values within the ranges specified below.
•Hemoglobin ≥ 9.0 g/L
•Absolute neutrophil count ≥ 1.5 x 10\^9/L
•Platelets ≥ 100 x 10\^9/L
•Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except participants with Gilbert's Syndrome, who are eligible with bilirubin ≤ 2.5 ULN)
•Alanine transaminase ≤ 2.5 xupper limit of normal (ULN), unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
•Aspartate aminotransferase ≤ 2.5 x ULN, unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
•The patient is on standard of care immunotherapy or combination of chemotherapy and immunotherapy with no evidence of progression or a candidate for chemoimmunotherapy as determined by the treating medical oncologist. Eligible patients that are currently on standard of care treatment will have the systemic therapy paused for 4-6 weeks prior to the surgery and intraoperative PDT and will resumed within 4-12 weeks after surgery following standard of care timeframe utilized for restarting systemic therapy after major surgical procedures to ensure adequate post-op recovery and tissue healing.
•Age \>= 18 years old

排除标准

•Patients who received chemotherapy, chemoimmunotherapy or radiotherapy within \<4 weeks (6 weeks for nitrosoureas or mitomycin C) or those who have not recovered from reversible adverse events prior to the scheduled surgery and intraoperative PDT.
•Patients with untreated or symptomatically unstable treated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with treated and stable brain metastases (at least 28 days from last radiotherapy treatment) are eligible as long as steroids are not required for symptom management
•Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
•Absolute neutrophil count \< 1500
•Left ventricular ejection fraction (LVEF) \< lower level of normal (LLN)
•Total bilirubin \> 2 mg/dL
•Creatinine clearance \< 60 mL/min (Cockcroft Gault equation)
•Alkaline phosphatase (hepatic) \> 3 times the upper normal limit (SGPT) \> 3 times the upper normal limit
•NOTE: Roswell Park clinical lab blood chemistry is performed on plasma unless otherwise indicated
•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

研究组 & 干预措施

Treatment (porfimer sodium, photodynamic therapy)

Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy

干预措施: Porfimer Sodium

Treatment (porfimer sodium, photodynamic therapy)

Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy

干预措施: Video-Assisted Thoracic Surgery

Treatment (porfimer sodium, photodynamic therapy)

Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy

干预措施: Photodynamic Therapy

Treatment (porfimer sodium, photodynamic therapy)

Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy

干预措施: Intraoperative PDT

结局指标

主要结局

Incidence of serious adverse events (SAE)

时间窗: 28 days post study-related immunotherapy

Will be determined by recording the occurrence of SAE during the first 28 days post study-related immunotherapy. The SAE will be evaluated using the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

次要结局

Progression-free survival (PFS)(assessed up to 1 year)
Overall survival (OS)(assessed up to 1year)
Changes in the immune phenotype of peripheral blood CD8+ T cells(Baseline up to 1year)
Changes in platelet-to-lymphocyte ratio(Baseline up to 1 year)