Phase II Trial of Radical Pleurectomy With or Without Intraoperative PDT for Malignant Pleural Mesothelioma

NCT02153229 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: UPCC 14513
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief 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 . All subjects will receive maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic light dosimetry.

Conditions

Epitheliod Malignant Pleural Mesothelioma

Keywords

Histological diagnosis of MPM; epitheliod subtype; limited to the hemithorax; macroscopically complete resection of the tumor

Outcome Measures

Primary Outcomes (1)

• Survival months

  4 years

Secondary Outcomes (3)

• Progression-free survival months

  4 years

• Local Control

  4 years

• Receipt of Pembrolizumab

  4 years

Study Arms (2)

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

Interventions

Chemotherapy RADIATION

patients who undergo RP alone; patients who undergo RP plus photofrin-based PDT

Photodynamic Therapy RADIATION

Also known as: PDT

patients who undergo RP plus photofrin-based PDT

Radical Pleurectomy PROCEDURE

Also known as: RP

patients who undergo RP alone; patients who undergo RP plus photofrin-based PDT

Photofrin 2.0 mg/kg DRUG

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

patients who undergo RP plus photofrin-based PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Drug Therapy; Dihematoporphyrin Ether

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Phototherapy; Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors

Study Officials

• Keith Cengel, MD, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 3, 2014
• Study Start: June 2, 2014
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (2)