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Photodynamic Therapy

Surgery + Photodynamic Therapy for Mesothelioma (MPM-PDT Trial)

Phase 2

Recruiting

Led By Keith Cengel, MD, PhD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0-1.

Subjects treated with pemetrexed previously will be eligible only if 30 days have elapsed between the last dose of pemetrexed and the date of surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

MPM-PDT Trial Summary

This trial is testing whether adding a light-based therapy to surgery and chemo can improve survival in people with a certain type of lung cancer.

Who is the study for?

This trial is for adults with epithelioid malignant pleural mesothelioma who can undergo complete tumor removal. They must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature. Prior treatments like surgery, gene therapy, or chemo are okay if it's been over 30 days since the last treatment.Check my eligibility

What is being tested?

The study is testing if adding Photofrin-mediated photodynamic therapy (PDT) during surgery improves survival compared to just surgery and post-op chemo. Participants will be randomly assigned to receive PDT or not before their radical pleurectomy—a surgical procedure to remove part of the lining of the lungs—and subsequent chemotherapy.See study design

What are the potential side effects?

Potential side effects include those related to Photofrin such as sensitivity to light, which could lead to burns if exposed too soon after treatment. Surgery may cause typical risks like bleeding and infection, while chemotherapy can result in nausea, fatigue, hair loss, and increased risk of infections.

MPM-PDT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can carry out all my daily activities without help.

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It has been over 30 days since my last pemetrexed treatment.

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I understand the risks and benefits of this study and can sign the consent form.

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My cancer is confined to one side of my chest.

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I am 18 years old or older.

MPM-PDT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Survival months

Secondary outcome measures

Local Control

Progression-free survival months

Receipt of Pembrolizumab

MPM-PDT Trial Design

2Treatment groups

Experimental Treatment

Group I: patients who undergo RP plus photofrin-based PDTExperimental Treatment4 Interventions

Group II: patients who undergo RP aloneExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Photodynamic Therapy

2014

Completed Phase 4

~460

Chemotherapy

2003

Completed Phase 4

~3050

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,562 Total Patients Enrolled

5 Trials studying Mesothelioma

87 Patients Enrolled for Mesothelioma

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

104,962 Total Patients Enrolled

5 Trials studying Mesothelioma

87 Patients Enrolled for Mesothelioma

Keith Cengel, MD, PhDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine

3 Previous Clinical Trials

9 Total Patients Enrolled

Media Library

Photodynamic Therapy (Photodynamic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02153229 — Phase 2

Mesothelioma Research Study Groups: patients who undergo RP alone, patients who undergo RP plus photofrin-based PDT

Mesothelioma Clinical Trial 2023: Photodynamic Therapy Highlights & Side Effects. Trial Name: NCT02153229 — Phase 2

Photodynamic Therapy (Photodynamic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02153229 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially validated Radical Pleurectomy as a treatment option?

"We appraised the safety of radical pleurectomy to be 2, owing to its Phase 2 status with limited data attesting to efficacy but some evidence of security."

Answered by AI

How many participants is this trial limited to?

"Affirmative. Evidence on clinicaltrials.gov reveals that this investigation is actively enrolling patients, with the first posting occuring on May 1st 2014 and a recent update being made July 25th 2022. 102 participants are desired between two distinct medical centres."

Answered by AI

Is it feasible for individuals to join this trial at present?

"Affirmative. Clinicaltrials.gov provides evidence that this medical experiment, first posted on May 1st 2014, is in need of participants to move forward with the trial. The study intends to recruit 102 individuals from 2 different locations."

Answered by AI

What former investigations have been conducted on Radical Pleurectomy?

"Currently, the landscape of Radical Pleurectomy clinical trials are in Phase 1 and 2. There is a concentration of studies running out of Philadelphia, Pennsylvania but 6 medical sites across the United States have active investigations into this procedure."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma

2014. "Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02153229.

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