Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-31 @ 3:32 PM
Study NCT ID:
NCT00054002
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2003-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D054363', 'term': 'Solitary Fibrous Tumor, Pleural'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D054364', 'term': 'Solitary Fibrous Tumors'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D017323', 'term': 'Dihematoporphyrin Ether'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D017324', 'term': 'Hematoporphyrin Derivative'}, {'id': 'D006415', 'term': 'Hematoporphyrins'}, {'id': 'D011166', 'term': 'Porphyrins'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-25', 'studyFirstSubmitDate': '2003-02-05', 'studyFirstSubmitQcDate': '2003-02-05', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '1 month, every 4 months for 2 years, and then every 6 months for 3 years'}, {'measure': 'Comparison of results from this regimen to historical controls', 'timeFrame': 'At completion of study'}, {'measure': 'Toxic effects', 'timeFrame': '1 month, every 4 months for 2 years, and then every 6 months for 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['localized malignant mesothelioma', 'recurrent malignant mesothelioma', 'epithelial mesothelioma', 'sarcomatous mesothelioma'], 'conditions': ['Malignant Mesothelioma']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery.\n* Compare results of this regimen in these patients to historical controls.\n* Determine the toxic effects of this regimen in these patients.\n\nOUTLINE: This is a pilot study.\n\nPatients receive porfimer sodium IV over 5-10 minutes on day 1. Patients undergo pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3.\n\nPatients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed malignant mesothelioma, including the following cell types:\n\n * Mixed mesothelial\n * Sarcomatous\n* Stage I or II disease using the Butchart system as determined by CT scan or MRI\n* Disease confined to 1 hemithorax\n* No tumor involvement of esophagus or heart as evidenced by CT scan\n\n * Pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest\n * N2 disease allowed if no contralateral pleural involvement\n* No adenocarcinoma or nonmesothelioma sarcoma of the chest wall\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC greater than 4,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin greater than 8.5 g/dL (transfusion allowed)\n\nHepatic\n\n* Bilirubin less than 3.0 mg/dL\n* Alkaline phosphatase less than 2 times upper limit of normal (ULN)\n* SGOT less than 2 times ULN\n\nRenal\n\n* Creatinine less than 3.0 mg/dL\n\nCardiovascular\n\n* No myocardial infarction within the past 6 months\n\nPulmonary\n\n* Arterial partial pressure of carbon dioxide (pCO\\_2) less than 50 torr at rest\n* Predicted postoperative FEV\\_1 at least 800 mL with maximum oxygen consumption/kg at least 15 mL/min\n* Predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation\n\nOther\n\n* Not pregnant\n* No other concurrent malignancy except nonmelanoma skin cancer\n* No contraindication to general anesthetic\n* No history of porphyria\n* No indicated sensitivity to porfimer sodium\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* More than 30 days since prior chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy to the chest\n* No prior radiotherapy for mesothelioma\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00054002', 'briefTitle': 'Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Surgery and Intracavitary Photodynamic Therapy (PDT) for the Treatment of Malignant Pleural Mesothelioma; The Use of Light Delivery Fibers With Large Diffusers', 'orgStudyIdInfo': {'id': 'CDR0000269674'}, 'secondaryIdInfos': [{'id': 'RPCI-RP-9812'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'description': 'Lung surgery'}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'description': 'Lung surgery'}, {'name': 'porfimer sodium', 'type': 'DRUG', 'description': 'iv'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Todd L. Demmy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Todd Demmy, MD', 'oldOrganization': 'Roswell Park Cancer Institute'}}}}