Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

NCT02106559 | Withdrawn DMC

• 2 other identifiers: OSU-12223NCI-2014-00637
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Pleural Photodynamic Therapy; Pleural Malignancy; PDT

Outcome Measures

Primary Outcomes (2)

• Number of patients who received the entire multi-modality regimen

  Up to 2 years

• Incidence of grade 4 or greater toxicity in the post-operative period as graded by the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects) version 4.0

  All observed toxicities will be graded, tabled and summarized by frequencies and percentages.

  Up to 90 days post surgery

Secondary Outcomes (4)

• Overall survival

  Time from study entry (start of chemotherapy) to death due to any cause or last patient contact, assessed up to 2 years

• Progression-free survival (PFS)

  Time from study entry to first documented progression (any type, intrapleural, distant, locoregional) or death due to any cause, assessed up to 2 years

• Pleural progression-free survival (PPFS)

  Time from surgery/PDT to first documented intrapleural progression or death from any cause, assessed up to 2 years

• Porfimer sodium uptake defined as the ratio of the porfimer sodium concentration in tumor tissue to normal tissue (i.e. skin) using spectrofluorometric assay

  After surgery

Study Arms (1)

Treatment (surgery, porfimer sodium, PDT)

EXPERIMENTAL

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.

Drug: porfimer sodium; Procedure: therapeutic conventional surgery; Drug: photodynamic therapy

Interventions

porfimer sodium DRUG

Given IV

Also known as: CL-184116, DHE, dihematoporphyrin ether, Photofrin II

Treatment (surgery, porfimer sodium, PDT)

therapeutic conventional surgery PROCEDURE

Undergo tumor resection and/or radical pleurectomy

Treatment (surgery, porfimer sodium, PDT)

photodynamic therapy DRUG

Undergo PDT

Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic

Treatment (surgery, porfimer sodium, PDT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Related Links

• The Jamesline

MeSH Terms

Conditions

Mesothelioma, Malignant; Carcinoma, Non-Small-Cell Lung

Interventions

Dihematoporphyrin Ether; Trioxsalen; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Meng Welliver

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 8, 2014
• Study Start: September 4, 2014
• Primary Completion: January 29, 2016
• Study Completion: January 29, 2016
• Last Updated: March 21, 2019

Record last verified: 2019-03