Phase II Pilot Study of Surgery and Adjuvant Intracavitary Photodynamic Therapy With Large Diffuser Fibers in Patients With Malignant Mesothelioma
Alternate Title: Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
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
Projected Accrual
A total of 20 patients will be accrued for this study within 3 years.
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.
Disclaimer
The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Trial Contact Information
Trial Lead Organizations
Roswell Park Cancer Institute
Todd Demmy, MD, Protocol chair
Ph: 716-845-5873; 800-767-9355
Trial Sites and Contacts
U.S.A.
New York
Buffalo
Roswell Park Cancer Institute
Todd Demmy, MD
Ph: 716-845-5873
800-767-9355
** POSTED JANUARY 26, 2003 **