Mesothelioma Related Clinical Trials:
Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers

• Feasibility [ Designated as safety issue: No ]
  
• Comparison of results from this regimen to historical controls [ Designated as safety issue: No ]
  
• Toxic effects [ Designated as safety issue: Yes ]
  

OBJECTIVES:

• 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.

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

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

Renal

• Creatinine less than 3.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months

Pulmonary

• 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

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 30 days since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

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

Surgery

• Not specified