In an ongoing study not currently accepting participants mesothelioma doctors at the Roswell Park Cancer Institute are studying the use of photodynamic therapy, a treatment that makes cancer cells more sensitive to light. The trial, which began in 2003, studies the effectiveness of combining photodynamic therapy with surgery in the treatment of mesothelioma.
The objectives of the study are to determine the feasibility of adjuvant photodynamic therapy in patients undergoing surgery, to compare results in these patients to historical controls and to determine the toxic effects of this regimen. As such, participants receive Porfimer Sodium IV over 5-10 minutes on day 1. Then patients undergo a pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3. Participants receive follow-ups at month1, then every 4 months for 2 years and then every 6 months for 3 years.
Mesothelioma is a rare type of cancer that occurs in the lining of the chest or abdomen and is more likely to develop in individuals who have been exposed to airborne asbestos particles. Typical mesothelioma treatment includes surgery, chemotherapy, radiation or a combination of the three.
The patients recruited for this study are male and female and 18 years or older with an ECOG of 0-2. There were no limitations regarding life expectancy, but hematopoietic, hepatic, renal, cardiovascular and pulmonary function had to be within specific ranges. Patients were not eligible if they were pregnant, had a concurrent malignancy (except nonmelanoma skin cancer), had a contraindication to general anesthetic, had a history of porphyria or indicated sensitivity to Porfimer Sodium.
Patients had to exhibit specific disease characteristics in order to participate in the trial. They had to have histologically or cytologically confirmed malignant mesothelioma, including mixed mesothelial and sarcomatous cell types. The disease had to be confined to 1 hemithorax and in stage I or II using the Butchart system as determined by CT scan or MRI. No tumor involvement in the esophagus or heart was allowed. However, pericardial or diaphragmatic involvement was allowable if disease was limited to the ipsilateral chest, as was N2 disease if there was no contralateral pleural involvement. Participants with adenocarcinoma or nonmesothelioma sarcoma of the chest wall were considered ineligible for participation.
Participants were not allowed to have undergone prior radiotherapy to the chest or radiotherapy for mesothelioma, nor were they to undergo chemotherapy 30 days prior to the beginning of the study. There were no specifications regarding biologic therapy, endocrine therapy or surgery.
The Surgery and Photodynamic Therapy in Treating Patients with Malignant Mesothelioma study is led by Todd L. Demmy, MD of the Roswell Park Cancer Institute in Buffalo, New York, and it was last updated on ClinicalTrials.gov on February 6, 2009.
For more information visit http://clinicaltrials.gov/ct2/show/NCT00054002?term=mesothelioma&rank=16 and refer to this study by its ClinicalTrials.gov identifier: NCT00054002.
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