Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI RPCI-RP-9812 NCT00054002

Objectives

1. Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery.
2. Compare results of this regimen in these patients to historical controls.
3. Determine the toxic effects of this regimen in these patients.

Entry Criteria

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 4,000/mm³
• Platelet count greater than 100,000/mm³
• 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 (pCO₂) less than 50 torr at rest
• Predicted postoperative FEV₁ 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

Expected Enrollment

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

Outcomes

Feasibility
Comparison of results from this regimen to historical controls
Toxic effects

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Todd Demmy, MD, Protocol chair		Ph: 716-845-5873; 800-685-6825

Registry Information
Official Title		Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers with Large Diffusers
Trial Start Date		1999-03-15
Registered in ClinicalTrials.gov		NCT00054002
Date Submitted to PDQ		2002-12-13
Information Last Verified		2006-12-11
NCI Grant/Contract Number		P30-CA16056

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