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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Roswell Park Cancer Institute
Buffalo, New York, United States
Start Date
February 21, 2014
Primary Completion Date
September 4, 2018
Completion Date
September 4, 2018
Last Updated
July 22, 2022
8
ACTUAL participants
Temoporfin
DRUG
Therapeutic Conventional Surgery
PROCEDURE
Photodynamic Therapy
DRUG
Laboratory Biomarker Analysis
OTHER
Pharmacological Study
OTHER
Lead Sponsor
Roswell Park Cancer Institute
NCT01629498
NCT02495896
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