Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
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ClinicalTrials.gov Identifier: NCT00054002 |
Recruitment Status :
Completed
First Posted : February 6, 2003
Last Update Posted : March 1, 2011
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Mesothelioma | Procedure: adjuvant therapy Procedure: conventional surgery Drug: porfimer sodium | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers |
Study Start Date : | March 1999 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | December 2010 |

- Procedure: adjuvant therapy
Lung surgery
- Procedure: conventional surgery
Lung surgery
- Drug: porfimer sodium
iv
- Feasibility [ Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years ]
- Comparison of results from this regimen to historical controls [ Time Frame: At completion of study ]
- Toxic effects [ Time Frame: 1 month, every 4 months for 2 years, and then every 6 months for 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054002
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Todd L. Demmy, MD | Roswell Park Cancer Institute |
Responsible Party: | Todd Demmy, MD, Roswell Park Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00054002 |
Other Study ID Numbers: |
CDR0000269674 RPCI-RP-9812 |
First Posted: | February 6, 2003 Key Record Dates |
Last Update Posted: | March 1, 2011 |
Last Verified: | February 2011 |
localized malignant mesothelioma recurrent malignant mesothelioma epithelial mesothelioma sarcomatous mesothelioma |
Mesothelioma Lung Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Dihematoporphyrin Ether Trioxsalen Antineoplastic Agents Dermatologic Agents Photosensitizing Agents |