Clinical trial · Interventional
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy
A Pilot Study of Pleural Photodynamic Therapy for Patients With Pleural Malignancy
- 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)
This pilot clinical trial studies photodynamic therapy during surgery in treating patients with pleural (the protective lining or membrane that covers the lungs and chest cavity) malignancy. Photodynamic therapy is an anti-cancer treatment that combines a photosensitizer (a substance that makes cells more sensitive to light), such as porfimer sodium, together with oxygen and visible light to kill tumor cells and/or damage the tumor's blood supply. Intraoperative (during surgery) photodynamic therapy may kill any tumor cells that remain after surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Stage IV Malignant Mesothelioma | Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| photodynamic therapy | Drug | — | UNRESOLVED |
| porfimer sodium | Drug | Porfimer | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (surgery, porfimer sodium, PDT)
- description
- Patients receive porfimer sodium IV over 3-5 minutes. Beginning 24 hours later, patients undergo tumor resection and/or radical pleurectomy followed by intraoperative photodynamic therapy to the pleural space.
- interventionNames
- Drug: porfimer sodium
- Procedure: therapeutic conventional surgery
- Drug: photodynamic therapy
Primary outcomes (2)
- measure
- Number of patients who received the entire multi-modality regimen
- timeFrame
- Up to 2 years
- measure
- Incidence of grade 4 or greater toxicity in the post-operative period as graded by the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects) version 4.0
- timeFrame
- Up to 90 days post surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of NSCLC or MPM; pts must have clinical and/or pathological evidence of pleural spread or stage III/IV MPM * Pts with NSCLC who have received, are receiving or are planning to receive two to four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not be permitted during the active study period; post-operative radiotherapy can be administered as clinically indicated * Assessment by the attending thoracic surgeon that the primary tumor is resectable in pts with NSCLC and pleural spread; tumor will be deemed resectable if there is no extension through fascia, no bony chest or vertebral body involvement, and no radiographic evidence of mediastinal involvement * Assessment by the attending thoracic surgeon that radical pleurectomy can be safely achieved in pts with malignant pleural mesothelioma * All studies required for evaluation will be performed within 8 weeks of Photofrin administration * Pts of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, then appropriate measures will be undertaken to attempt to increase participation of pts of that minority or gender group * ELIGIBILITY CRITERIA FOR HISTORICAL CONTROL POPULATION * Pts undergoing extrapleural pneumonectomy without PDT for MPM or stage IV (M1A) NSCLC (after American Joint Committee on Cancer \[AJCC\] staging change 2010) or stage IIIB (before staging change) with malignant pleural effusion treated at Ohio State University (OSU) from 2005-2012 * Historical control data will be derived from patient medical records at the Ohio State University Medical Center (OSUMC) Exclusion Criteria: * Pts who have grade III-IV elevations in liver transaminases (as defined by the Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 4.0) or a bilirubin in excess of 1.5 mg/dl * Pts who are medically unfit to tolerate surgery * Pts with known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) disease (routine testing is not needed if not clinical indicated) * Pregnant or lactating pts * Prior treatment for NSCLC except for pleurodesis and/or standard frontline chemotherapy * Pts who have received prior mantle or extensive mediastinal radiation
References
Publications (0)
Data not yet available