Trial Information

A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-Small Cell Lung Cancer and Pleural Spread

OBJECTIVES:

Primary

- To determine the overall survival rate of patients with non-small cell lung cancer
(NSCLC) and malignant pleural spread treated with standard front-line chemotherapy
followed by surgical resection and intra-operative porfimer sodium
(Photofrin®)-mediated photodynamic therapy.

- To determine the feasibility and toxicities of standard front-line chemotherapy
followed by surgical resection and intra-operative Photofrin®-mediated photodynamic
therapy in these patients.

Secondary

- To determine the progression-free survival and pleural progression-free survival of
these patients.

- To determine the absolute Photofrin® levels in tumor and normal tissues resected from
these patients using spectrofluorometric methods.

- To determine the tumor to normal tissue ratios of Photofrin® in these patients.

- To measure the optical properties of tumor and normal tissues in situ.

- To compare the Photofrin® concentration of tumor and normal tissues made with the in
situ measurements to the measurements made with spectrofluorometric method.

OUTLINE: This is a multicenter study.

Patients receive 2-4 courses of standard front-line chemotherapy prior to surgery (if they
have not completed the front-line chemotherapy).

Patients receive porfimer sodium (Photofrin®) IV over 5-15 minutes. Approximately 24 hours
after receiving porfimer sodium, patients undergo surgery to remove the primary tumor and
the pleural disease to a thickness of 5 mm or less*. Patients then undergo intraoperative
photodynamic therapy to the residual disease. Some patients may undergo postoperative
radiotherapy to the mediastinum and/or surgical scar if clinically indicated.

NOTE: *If the disease cannot be resected to less than 5 mm, PDT will not be delivered

Tumor and normal tissue samples are obtained from the surgical specimen and examined prior
to light delivery at the time of thoracotomy, and after light delivery. Tissue samples are
analyzed for porphyrin levels using a spectrofluorometric assay of tissue specimens and an
in situ optical method intra-operatively. Samples are also assessed for V-cadherin, markers
for oxidative stress, markers associated with photosensitizer uptake, markers for
angiogenesis, markers for hypoxia, activation of signaling pathway components (including
EGFR, p38 MAPK, Akt, and p42/44 MAPK) via immunohistochemistry.

After completion of study treatment, patients are followed periodically for 2 years.