Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Dihematoporphyrin Ether; Trioxsalen

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

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