Photodynamic Therapy in Treating Patients With Resectable Non-Small Cell Lung Cancer That Has Spread to the Pleura

Phase 2

Terminated

• Conditions: Lung Cancer; Metastatic Cancer
• Interventions: Drug: chemotherapy; Drug: porfimer sodium; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: spectroscopy; Procedure: therapeutic conventional surgery

• Registration Number: NCT00601848
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Primary Completion: 2012-02
• Study Completion: 2012-12
• Status Verified: 2020-04
• Results First Submitted: 2020-04-24
• Results First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Results First Posted: 2020-11-24
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photodynamic Therapy	laboratory biomarker analysis	PDT
Photodynamic Therapy	chemotherapy	PDT
Photodynamic Therapy	spectroscopy	PDT
Photodynamic Therapy	therapeutic conventional surgery	PDT
Photodynamic Therapy	immunohistochemistry staining method	PDT
Photodynamic Therapy	porfimer sodium	PDT

Primary Outcome Measures

Name	Time	Method
Toxicity Assessment of Pleural Photodynamic Therapy	One year	Toxicities of PDT as defined by CTCAE v4.0
Pleural Progression-free Survival	5 years	Amount of time from PDT to disease progression in pleura
Overall Survival	5 years	Subject survival post PDT

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	5 years	Amount of time from PDT to disease progression at any site in the body
Photofrin® Uptake	90 days	Measured uptake of PDT drug

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States