A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) in Patients With Resectable Primary Non-Small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease
I. To demonstrate that intraoperative adjuvant regional photodynamic therapy with HPPH is
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
IV. To measure HPPH uptake in malignant and normal tissue.
OUTLINE: This is a dose-escalation study of photodynamic therapy with HPPH.
Patients receive HPPH intravenously (IV) over 1 hour 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of PDT with HPPH, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity (DLT) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|