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Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma

Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00054002
Enrollment
12
Registered
2003-02-06
Start date
1999-03-31
Completion date
2010-12-31
Last updated
2011-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesothelioma, recurrent malignant mesothelioma, epithelial mesothelioma, sarcomatous mesothelioma

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.

Interventions

PROCEDUREadjuvant therapy

Lung surgery

PROCEDUREconventional surgery

Lung surgery

DRUGporfimer sodium

iv

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Feasibility1 month, every 4 months for 2 years, and then every 6 months for 3 years
Comparison of results from this regimen to historical controlsAt completion of study
Toxic effects1 month, every 4 months for 2 years, and then every 6 months for 3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026