Spots Global Cancer Trial Database for Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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