photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery

Conditions: Recurrent Non-Small Cell Lung Carcinoma; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIB Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer

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.

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.

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 * 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