Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

NCT ID: NCT02106559

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-04
• Study Completion Date: 2016-01-29

Brief Summary

This pilot clinical trial studies photodynamic therapy during surgery in treating patients with pleural (the protective lining or membrane that covers the lungs and chest cavity) malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer (a substance that makes cells more sensitive to light), such as porfimer sodium, together with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply. Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain after surgery.

Detailed Description

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.

Conditions

Stage III Malignant Mesothelioma; Stage IIIB Non-small Cell Lung Cancer; Stage IV Malignant Mesothelioma; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (surgery, porfimer sodium, PDT)

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

Group Type: EXPERIMENTAL

porfimer sodium

Intervention Type: DRUG

Given IV

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo tumor resection and/or radical pleurectomy

photodynamic therapy

Intervention Type: DRUG

Undergo PDT

Interventions

porfimer sodium

Given IV

Intervention Type: DRUG

therapeutic conventional surgery

Undergo tumor resection and/or radical pleurectomy

Intervention Type: PROCEDURE

photodynamic therapy

Undergo PDT

Intervention Type: DRUG

Other Intervention Names

CL-184116; DHE; dihematoporphyrin ether; Photofrin II; Light Infusion Therapy™; PDT; therapy, photodynamic

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Meng Welliver

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meng Welliver

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2014-00637

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-12223

Identifier Type: -

Identifier Source: org_study_id