A Phase II Study of Pleural Photodynamic Therapy for Patients With Non-small Cell Lung Cancer and Pleural Spread
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Toxicity Assessment of Pleural Photodynamic Therapy
Study Overview
Brief Summary
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy during surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy given during surgery works in treating patients with resectable non-small cell lung cancer that has spread to the pleura.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Photodynamic Therapy
PDT
Intervention: chemotherapy (Drug)
Photodynamic Therapy
PDT
Intervention: porfimer sodium (Drug)
Photodynamic Therapy
PDT
Intervention: immunohistochemistry staining method (Other)
Photodynamic Therapy
PDT
Intervention: laboratory biomarker analysis (Other)
Photodynamic Therapy
PDT
Intervention: spectroscopy (Procedure)
Photodynamic Therapy
PDT
Intervention: therapeutic conventional surgery (Procedure)
Outcomes
Primary Outcomes
Toxicity Assessment of Pleural Photodynamic Therapy
Time Frame: One year
Toxicities of PDT as defined by CTCAE v4.0
Overall Survival
Time Frame: 5 years
Subject survival post PDT
Pleural Progression-free Survival
Time Frame: 5 years
Amount of time from PDT to disease progression in pleura
Secondary Outcomes
- Progression-free Survival(5 years)
- Photofrin® Uptake(90 days)