A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) With Temoporfin in Patients With Resectable Primary Non-small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
研究概览
简要总结
This phase I trial studies the side effects and best dose of photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery. Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be a better way to treat patients with non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To demonstrate that intraoperative adjuvant regional photodynamic therapy with low-dose temoporfin is safe.
SECONDARY OBJECTIVES:
I. Initial assessment of efficacy (i.e., 2-year disease free survival). II. To investigate the relationship between signal transducer and activator of transcription 3 (STAT3) levels, measured light dose and the clinical outcome.
III. Correlate the serum concentrations of vitamin D metabolites (25-hydroxyvitarnin D3 and 1,25-dihydroxyvitamin D3) with the presence of lymph node (LN) metastasis at the time of surgical resection.
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 confirmed non-small cell lung cancer (NSCLC)
- •Patients with resectable primary NSCLC who are undergoing surgery to resect T3 to T4 lesions OR any patients with clinical NI or N2 disease regardless of T-stage
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2
- •Subjects 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 and for 6 months after surgery; 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
- •The subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure
- •Must consent to participate in study I 03103: Roswell Park Cancer Institute (RPCI) Data Bank and Biorepository (DBBR)
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Patients with known brain metastases should be excluded from this clinical trial
- •Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
- •White blood cell (WBC) < 4,000
- •Platelet count < 100,000
- •Total serum bilirubin > 2 mg/dL
- •Serum creatinine > 2 mg/dL
- •Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
- •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 subjects
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive study drug
- •Received an investigational agent within 30 days prior to enrollment
研究组 & 干预措施
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
干预措施: Temoporfin (Drug)
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
干预措施: Therapeutic Conventional Surgery (Procedure)
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
干预措施: Photodynamic Therapy (Drug)
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
干预措施: Pharmacological Study (Other)
结局指标
主要结局
Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
时间窗: 2 weeks
次要结局
- Progression free survival(Up to 2 years)
- Overall survival(Up to 2 years)
- Toxicity rate, using NCI CTCAE version 4(Up to 30 days after completion of study treatment)
- Locoregional recurrence-free rate(Up to 2 years)