Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers
18 Years
N/A
Both
Malignant Mesothelioma
Trial Information
Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility
Outcome Time Frame:
1 month, every 4 months for 2 years, and then every 6 months for 3 years
Safety Issue:
No
Principal Investigator
Todd L. Demmy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000269674
NCT ID:
NCT00054002
Start Date:
March 1999
Completion Date:
December 2010
Related Keywords:
- Malignant Mesothelioma
- localized malignant mesothelioma
- recurrent malignant mesothelioma
- epithelial mesothelioma
- sarcomatous mesothelioma
- Mesothelioma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
