NCT02153229Active, not recruitingPhase 2
Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma
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
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 28 May 2014
- Start date
- 2 Jun 2014
- Primary completion date
- 16 Dec 2026
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Mesothelioma
- NCT number
- NCT02153229
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 52
- From 2 Jun 2014 to the primary completion date, 16 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Subjects who have received more than 2 doses of neo-adjuvant chemotherapy
Other illness
- 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
- Patients who have a history of HIV disease.
- Patients with porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
- Patients with distant metastatic disease or otherwise not confined to the ipsilateral hemithorax.
Lab values
- 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.
Other
- Pregnant or lactating patients.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.