Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) January 2006
| Sponsors and Collaborators: |
Roswell Park Cancer Institute
|
| Information provided by: |
National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: |
NCT00054002 | |
Purpose
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 |
Intervention |
Phase |
Localized Malignant Mesothelioma
Recurrent Malignant Mesothelioma
Epithelial Mesothelioma
Sarcomatous Mesothelioma
|
Drug: porfimer sodium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: laser therapy
Procedure: photodynamic therapy
Procedure: phototherapy
Procedure: surgery
|
Phase II
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Mesothelioma
Genetics Home Reference related topics: Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Pilot Study of Surgery and Adjuvant Intracavitary Photodynamic Therapy With Large Diffuser Fibers in Patients With Malignant Mesothelioma
Further study details as provided by National Cancer Institute (NCI):
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Performance status
Life expectancy
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
Chemotherapy
- More than 30 days since prior chemotherapy
Endocrine therapy
Radiotherapy
- No prior radiotherapy to the chest
- No prior radiotherapy for mesothelioma
Surgery
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00054002
New York Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Clinical Trials Office - Roswell Park Cancer Institute 716-845-8734
Study chairs or principal investigators
Todd L. Demmy, MD, Study Chair, Roswell Park Cancer Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000269674; RPCI-RP-9812
Last Updated: February 6, 2006
Record first received: February 5, 2003
ClinicalTrials.gov Identifier:
NCT00054002Health Authority: United States: Federal Government
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