Brief Title
Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
Official Title
Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers
Brief 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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Feasibility
Condition
Malignant Mesothelioma
Intervention
adjuvant therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
12
Start Date
March 1999
Completion Date
December 2010
Primary Completion Date
June 2006
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Todd L. Demmy, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00054002
Organization ID
CDR0000269674
Secondary IDs
RPCI-RP-9812
Study Sponsor
Roswell Park Cancer Institute
Study Sponsor
Todd L. Demmy, MD, Study Chair, Roswell Park Cancer Institute
Verification Date
February 2011