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

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.

Study Type: Interventional

Study Design: Treatment

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.

Intervention(s) in this Clinical Trial

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

Primary Measures

• Feasibility
  • Safety Issue?: No
• Comparison of results from this regimen to historical controls
  • Safety Issue?: No
• Toxic effects
  • Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Roswell Park Cancer Institute

Overall Clinical Trial Officials and Contacts

Todd L. Demmy, MD Study Chair Roswell Park Cancer Institute  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00054002

Study ID Number: CDR0000269674

ClinicalTrials.gov Identifier: NCT00054002

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database