Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

PRIMARY OBJECTIVES; I. To determine the feasibility and toxicities of incorporating surgical
resection and intra-operative Photofrin (porfimer sodium)-mediated photodynamic therapy in
patients (pts) with malignant pleural mesothelioma (MPM) or non-small cell lung cancer
(NSCLC) with pleural spread.

SECONDARY OBJECTIVES:

I. To determine the overall survival rate of pts with NSCLC and pleural spread treated with
standard frontline chemotherapy followed by surgical resection and intra-operative
Photofrin-mediated photodynamic therapy.

II. To determine the overall survival rate of pts with MPM after radical pleurectomy and
intraoperative Photofrin-mediated photodynamic therapy (PDT).

III. To determine the progression-free survival and pleural progression-free survival in the
above mentioned pts.

IV. To determine the absolute Photofrin levels in tumor and normal tissues resected from pts
using spectrofluorometric assay. Photofrin levels in tumor to normal tissue ratios will be
determined.

OUTLINE:

Patients receive porfimer sodium intravenously (IV) over 3-5 minutes. Beginning 24 hours
later, patients undergo tumor resection and/or radical pleurectomy followed by
intraoperative PDT to the pleural space.

After completion of treatment, patients are followed up at 3, 6, 9, 12 and 24 months.

Inclusion Criteria:

- Histological diagnosis of NSCLC or MPM; pts must have clinical and/or pathological
evidence of pleural spread or stage III/IV MPM

- Pts with NSCLC who have received, are receiving or are planning to receive two to
four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy
is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not
be permitted during the active study period; post-operative radiotherapy can be
administered as clinically indicated

- Assessment by the attending thoracic surgeon that the primary tumor is resectable in
pts with NSCLC and pleural spread; tumor will be deemed resectable if there is no
extension through fascia, no bony chest or vertebral body involvement, and no
radiographic evidence of mediastinal involvement

- Assessment by the attending thoracic surgeon that radical pleurectomy can be safely
achieved in pts with malignant pleural mesothelioma

- All studies required for evaluation will be performed within 8 weeks of Photofrin
administration

- Pts of all ethnic and gender groups will be included; protocol accrual will be
reviewed annually to include a determination of minority and gender representation;
if accrual demonstrates under-representation of any group with comparison to disease
incidence in that group, then appropriate measures will be undertaken to attempt to
increase participation of pts of that minority or gender group

- ELIGIBILITY CRITERIA FOR HISTORICAL CONTROL POPULATION

- Pts undergoing extrapleural pneumonectomy without PDT for MPM or stage IV (M1A) NSCLC
(after American Joint Committee on Cancer [AJCC] staging change 2010) or stage IIIB
(before staging change) with malignant pleural effusion treated at Ohio State
University (OSU) from 2005-2012

- Historical control data will be derived from patient medical records at the Ohio
State University Medical Center (OSUMC)

Exclusion Criteria:

- Pts who have grade III-IV elevations in liver transaminases (as defined by the Common
Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.0) or a bilirubin in
excess of 1.5 mg/dl

- Pts who are medically unfit to tolerate surgery

- Pts with known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) disease
(routine testing is not needed if not clinical indicated)

- Pregnant or lactating pts

- Prior treatment for NSCLC except for pleurodesis and/or standard frontline
chemotherapy

- Pts who have received prior mantle or extensive mediastinal radiation