Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery

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.

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