Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma


RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Combining photodynamic therapy with surgery may be an effective treatment for malignant mesothelioma.

PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma.

Full Title of Study: “Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2006

Detailed Description


- Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery.

- Compare results of this regimen in these patients to historical controls.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a pilot study.

Patients receive porfimer sodium IV over 5-10 minutes on day 1. Patients undergo pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3.

Patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.


  • Procedure: adjuvant therapy
    • Lung surgery
  • Procedure: conventional surgery
    • Lung surgery
  • Drug: porfimer sodium
    • iv

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility
    • Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years
  • Comparison of results from this regimen to historical controls
    • Time Frame: At completion of study
  • Toxic effects
    • Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years

Participating in This Clinical Trial


  • Histologically or cytologically confirmed malignant mesothelioma, including the following cell types:
  • Mixed mesothelial
  • Sarcomatous
  • Stage I or II disease using the Butchart system as determined by CT scan or MRI
  • Disease confined to 1 hemithorax
  • No tumor involvement of esophagus or heart as evidenced by CT scan
  • Pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest
  • N2 disease allowed if no contralateral pleural involvement
  • No adenocarcinoma or nonmesothelioma sarcoma of the chest wall



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8.5 g/dL (transfusion allowed)


  • Bilirubin less than 3.0 mg/dL
  • Alkaline phosphatase less than 2 times upper limit of normal (ULN)
  • SGOT less than 2 times ULN


  • Creatinine less than 3.0 mg/dL


  • No myocardial infarction within the past 6 months


  • Arterial partial pressure of carbon dioxide (pCO_2) less than 50 torr at rest
  • Predicted postoperative FEV_1 at least 800 mL with maximum oxygen consumption/kg at least 15 mL/min
  • Predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation


  • Not pregnant
  • No other concurrent malignancy except nonmelanoma skin cancer
  • No contraindication to general anesthetic
  • No history of porphyria
  • No indicated sensitivity to porfimer sodium


Biologic therapy

  • Not specified


  • More than 30 days since prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy to the chest
  • No prior radiotherapy for mesothelioma


  • Not specified

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Roswell Park Cancer Institute
  • Provider of Information About this Clinical Study
    • Todd Demmy, MD, Roswell Park Cancer Institute
  • Overall Official(s)
    • Todd L. Demmy, MD, Study Chair, Roswell Park Cancer Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.