Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epitheliod Malignant Pleural Mesothelioma | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Radiation | — | UNRESOLVED |
| Photodynamic Therapy | Radiation | — | UNRESOLVED |
| Photofrin 2.0 mg/kg | Drug | Porfimer | ALIAS |
| Radical Pleurectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- patients who undergo RP plus photofrin-based PDT
- interventionNames
- Radiation: Photodynamic Therapy
- Procedure: Radical Pleurectomy
- Radiation: Chemotherapy
- Drug: Photofrin 2.0 mg/kg
- type
- EXPERIMENTAL
- label
- patients who undergo RP alone
- interventionNames
- Procedure: Radical Pleurectomy
- Radiation: Chemotherapy
Primary outcomes (1)
- measure
- Survival months
- timeFrame
- 4 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. EXCLUSION CRITERIA * 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. * 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
References
Publications (1)
- DERIVEDSun 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. PMID 39838651