Epitheliod Malignant Pleural MesotheliomaPhase 2MPM-PDTNCT02153229
Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma
A Phase 2 study testing Photodynamic Therapy, Radical Pleurectomy and Chemotherapy in people with Epitheliod Malignant Pleural Mesothelioma, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given the photosensitizer prior to surgery . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epitheliod Malignant Pleural Mesothelioma
- What is being tested?
- Photodynamic Therapy, Radical Pleurectomy and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2014to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a histologic diagnosis of MPM, epithelioid subtype, who in the opinion of the attending thoracic surgeon can receive a macroscopically complete resection of tumor.
- Patients must have disease limited to the hemithorax.
- Patients who have received prior surgery, gene therapy, or combination chemotherapy will be permitted if it has been at least 30 days since the last treatment.
- 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.
- ECOG performance status of 0-1.
- Medical suitability for resection, including documented medical and cardiac clearance.
- 18 years of age or older.
- Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable due to cognitive impairment to sign informed consent are excluded from the study.
Who cannot join
- Patients with active invasive cancers, other than MPM, that require additional treatment, except non-melanomatous skin cancer, superficial bladder or cervical cancer, and early-stage prostate cancer
- Pregnant or lactating patients.
- Patients who have a history of HIV disease.
- Patients who have a white count less than 2,500 per cubic mm or platelets less than 100,000/cubic mm.
- Serum creatinine equal or greater than 2.5 mg/deciliter.
- 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.
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- Patients with porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
- Patients who have been treated with pemetrexed if the last dose of pemetrexed is < 30 days to the date of surgery.
- Patients that have been treated with prior Mantle field radiation.
- Patients with distant metastatic disease or otherwise not confined to the ipsilateral hemithorax.
- Subjects who have received more than 2 doses of neo-adjuvant chemotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Phase 2 Trial of Radical Pleurectomy and Post-Operative Chemotherapy With or Without Intraoperative Porfimer Sodium -Mediated Photodynamic Therapy for Patients With Epitheliod Malignant Pleural Mesothelioma
A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given the photosensitizer prior to surgery . All subjects will receive maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic light dosimetry.
- Being tested
- Photodynamic Therapy, Radical Pleurectomy, Chemotherapy, Photofrin 2.0 mg/kg
- Keywords
- Histological diagnosis of MPM, epitheliod subtype, limited to the hemithorax, macroscopically complete resection of the tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic TherapyRadiation
Also called PDT
Radical PleurectomyProcedure or surgery
Also called RP
ChemotherapyRadiation
Photofrin 2.0 mg/kgDrug
If randomized to the RP with PDT arm, subject will receive Photofrin 2.0 mg/kg as an intravenous infusion 24 hours (range 18-30 hours) prior to intra-operative light delivery (PDT) during radical pleurectectomy
| Study group | Role | What they receive |
|---|---|---|
| patients who undergo RP plus photofrin-based PDT | Experimental | Not described Receives: Radiation: Photodynamic Therapy; Procedure: Radical Pleurectomy; Radiation: Chemotherapy; Drug: Photofrin 2.0 mg/kg |
| patients who undergo RP alone | Experimental | Not described Receives: Procedure: Radical Pleurectomy; Radiation: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival months
Measured: 4 years
Secondary outcomes (3)
Progression-free survival months
Measured: 4 years
Local Control
progression with death as a competing risk
Measured: 4 years
Receipt of Pembrolizumab
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start2 Jun 2014
- Primary completion16 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epitheliod Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Cengel, MD, PhD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153229
- Sponsor's protocol ID
- UPCC 14513
- Acronym
- MPM-PDT
- Status last verified
- Dec 2025
- First submitted
- 28 May 2014
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sun H, Kim MM, Ong YH, Dimofte A, Singhal S, Busch TM, Cengel KA, Zhu TC. Comprehensive reanalysis of light fluence distribution in pleural photodynamic therapy using standardized anatomical coordinates. Photochem Photobiol. 2025 Sep-Oct;101(5):1165-1176. doi: 10.1111/php.14063. Epub 2025 Jan 21.
PubMed 39838651
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial of Radical Pleurectomy and Post-Operative Chemotherapy With or Without Intraoperative Porfimer Sodium -Mediated Photodynamic Therapy for Patients With Epitheliod Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT02153229
- Acronym / sponsor ID
- MPM-PDT / UPCC 14513
- Keywords
- Histological diagnosis of MPM, epitheliod subtype, limited to the hemithorax, macroscopically complete resection of the tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 2 Jun 2014 (actual)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given the photosensitizer prior to surgery . All subjects will receive maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic light dosimetry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who undergo RP plus photofrin-based PDT | Experimental | Radiation: Photodynamic Therapy, Procedure: Radical Pleurectomy, Radiation: Chemotherapy, Drug: Photofrin 2.0 mg/kg |
| patients who undergo RP alone | Experimental | Procedure: Radical Pleurectomy, Radiation: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a histologic diagnosis of MPM, epithelioid subtype, who in the opinion of the attending thoracic surgeon can receive a macroscopically complete resection of tumor.
- Patients must have disease limited to the hemithorax.
- Patients who have received prior surgery, gene therapy, or combination chemotherapy will be permitted if it has been at least 30 days since the last treatment.
- 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.
- ECOG performance status of 0-1.
Key exclusion criteria (11 listed)
- Patients with active invasive cancers, other than MPM, that require additional treatment, except non-melanomatous skin cancer, superficial bladder or cervical cancer, and early-stage prostate cancer
- Pregnant or lactating patients.
- Patients who have a history of HIV disease.
- Patients who have a white count less than 2,500 per cubic mm or platelets less than 100,000/cubic mm.
- Serum creatinine equal or greater than 2.5 mg/deciliter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic TherapyAlso: PDT | Radiation | patients who undergo RP plus photofrin-based PDT |
| Radical PleurectomyAlso: RP | Procedure or surgery | patients who undergo RP alone, patients who undergo RP plus photofrin-based PDT |
| Chemotherapy | Radiation | patients who undergo RP alone, patients who undergo RP plus photofrin-based PDT |
| Photofrin 2.0 mg/kgIf randomized to the RP with PDT arm, subject will receive Photofrin 2.0 mg/kg as an intravenous infusion 24 hours (range 18-30 hours) prior to intra-operative light delivery (PDT) during radical pleurectectomy | Drug | patients who undergo RP plus photofrin-based PDT |
Primary outcome
Survival months
Time frame: 4 years
3 secondary outcomes
Progression-free survival months
Time frame: 4 years
Local Control
Time frame: 4 years
Receipt of Pembrolizumab
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 39838651Sun H, Kim MM, Ong YH, Dimofte A, Singhal S, Busch TM, Cengel KA, Zhu TC. Comprehensive reanalysis of light fluence distribution in pleural photodynamic therapy using standardized anatomical coordinates. Photochem Photobiol. 2025 Sep-Oct;101(5):1165-1176. doi: 10.1111/php.14063. Epub 2025 Jan 21.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Cengel, MD, PhD principal investigator
Abramson Cancer Center at Penn Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photodynamic Therapy, Radical Pleurectomy and Chemotherapy in people with Epitheliod Malignant Pleural Mesothelioma, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival months (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02153229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.