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Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

Primary Purpose

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

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

porfimer sodium

therapeutic conventional surgery

photodynamic therapy

About this trial

This is an interventional treatment trial for Stage III Malignant Mesothelioma focused on measuring Pleural Photodynamic Therapy, Pleural Malignancy, PDT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (surgery, porfimer sodium, PDT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients who received the entire multi-modality regimen

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.

Secondary Outcome Measures

Overall survival

Estimated by the method of Kaplan and Meier. Overall survival will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.

Progression-free survival (PFS)

Estimated by the method of Kaplan and Meier. PFS will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.

Pleural progression-free survival (PPFS)

Estimated by the method of Kaplan and Meier. PPFS will be estimated for the subset of patients who receive PDT, in order to evaluate the impact of PDT on local control. Survival curves will be plotted. Median and 1-year estimates and confidence intervals will be calculated.

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

Porfimer sodium concentration in the tissue will be calculated based on the increase in fluorescence resulting from the addition of a known amount of porfimer sodium to each sample after its initial reading. Absolute concentrations of porfimer sodium will also be measured. Distribution of uptake will be summarized by mean, median, standard deviation, range, and histogram. The tumor: normal tissue ratio from direct and indirect measurements will be calculated. Spearman's correlation will be employed to correlate and compare direct and indirect measurements.

Full Information

NCT ID

NCT02106559

First Posted

April 1, 2014

Last Updated

March 19, 2019

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02106559

Brief Title

Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

Official Title

A Pilot Study of Pleural Photodynamic Therapy for Patients With Pleural Malignancy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Withdrawn

Study Start Date

September 4, 2014 (Actual)

Primary Completion Date

January 29, 2016 (Actual)

Study Completion Date

January 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (surgery, porfimer sodium, PDT)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

porfimer sodium

Other Intervention Name(s)

CL-184116, DHE, dihematoporphyrin ether, Photofrin II

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Description

Undergo tumor resection and/or radical pleurectomy

Intervention Type

Drug

Intervention Name(s)

photodynamic therapy

Other Intervention Name(s)

Light Infusion Therapy™, PDT, therapy, photodynamic

Intervention Description

Undergo PDT

Primary Outcome Measure Information:

Title

Number of patients who received the entire multi-modality regimen

Time Frame

Up to 2 years

Title

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

Description

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

Time Frame

Up to 90 days post surgery

Secondary Outcome Measure Information:

Title

Overall survival

Description

Estimated by the method of Kaplan and Meier. Overall survival will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.

Time Frame

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

Title

Progression-free survival (PFS)

Description

Estimated by the method of Kaplan and Meier. PFS will be estimated for all patients entered on trial, regardless of treatment received on-study or off-study.

Time Frame

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

Title

Pleural progression-free survival (PPFS)

Description

Time Frame

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

Title

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

Description

Time Frame

After surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meng Welliver

Organizational Affiliation

Ohio State University Comprehensive Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

http://cancer.osu.edu

Description

The Jamesline

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Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy

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