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
Overview
- Phase
- Phase 1
- Intervention
- Temoporfin
- Conditions
- Recurrent Non-Small Cell Lung Carcinoma
- Sponsor
- Roswell Park Cancer Institute
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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. IV. To measure temoporfin uptake in malignant and normal tissue. OUTLINE: This is a dose-escalation study of photodynamic therapy with temoporfin. Patients receive temoporfin intravenously (IV) over no less than 6 minutes and then undergo standard surgical resection with intraoperative photodynamic therapy (PDT). After completion of study treatment, patients are followed up every 6 months for 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
Intervention: Temoporfin
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
Intervention: Therapeutic Conventional Surgery
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
Intervention: Photodynamic Therapy
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
Intervention: Laboratory Biomarker Analysis
Treatment (surgery and intraoperative PDT)
Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
Intervention: Pharmacological Study
Outcomes
Primary Outcomes
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
Time Frame: 2 weeks
Secondary Outcomes
- 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)