Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery

PRIMARY OBJECTIVES:

I. To demonstrate that our light dosimetry system is safe and effective in guiding
intraoperative photodynamic therapy with porfimer sodium (Photofrin).

SECONDARY OBJECTIVES:

I. To evaluate progression free survival (PFS) and overall survival (OS). II. To examine the
relationship between immune biomarkers and response.

OUTLINE:

Participants receive porfimer sodium intravenously (IV) over 3-5 minutes and receive
intraoperative photodynamic therapy (IO-PDT) via a light dosimetry system 24-48 hours later.

After conclusion of study treatment, participants are followed up at 30 days, within 4 weeks
from surgery and PDT and every 6 months for 2 years.

Inclusion Criteria:

- Histologically confirmed mesothelioma or non-small cell lung cancer (NSCLC) with
pleural disease without distant disease.

- 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.

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
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse events.

- White blood cell (WBC) < 4,000.

- Platelet count < 100,000.

- Total serum bilirubin > 2 mg/dL.

- Serum creatinine > 2 mg/dL.

- Alkaline phosphatase > 3 times the upper normal limit.

- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate
transaminase (SGPT) > 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 porfimer sodium.

- Received an investigational agent within 30 days prior to enrollment.