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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.
Must not have
Patients who have severe liver disease including cirrhosis, Grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/deciliter.
Patients who have a history of HIV disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe liver disease or very high liver test results.
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I have a history of HIV.
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I have received Mantle field radiation before.
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I have received more than 2 rounds of chemotherapy before surgery.
Select...
My cancer has spread beyond one side of my chest.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Local Control

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Chemotherapy
2003
Completed Phase 4
~3050
Photodynamic Therapy
2014
Completed Phase 4
~460

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
415 Previous Clinical Trials
464,604 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
108,402 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
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