Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-26 @ 7:19 PM
Study NCT ID:
NCT00014066
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2001-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017324', 'term': 'Hematoporphyrin Derivative'}, {'id': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'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'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2001-04-10', 'studyFirstSubmitQcDate': '2004-02-03', 'lastUpdatePostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I non-small cell lung cancer', 'recurrent non-small cell lung cancer', 'limited stage small cell lung cancer', 'recurrent small cell lung cancer', 'stage 0 non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Photodynamic therapy uses light and drugs that make cnacer cells more sensitive to light to kill tumor cells. Brachytherapy uses radiation to damage tumor cells. Photodynamic therapy combined with brachytherapy may kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of photodynamic therapy plus brachytherapy in treating patients with recurrent lung cancer that is blocking the lung passages.', 'detailedDescription': 'OBJECTIVES: I. Determine the feasibility, toxicity, and effectiveness of combination therapy with Photofrin PDT and HDT brachytherapy in patients with endobronchial obstructions from lung cancer.\n\nOUTLINE: This is not a randomized study. Photofrin solution is administered slowly as a bolus injection over 3-5 minutes on day 1. Bronchoscopy is performed under general anesthesia 48 hours after Photofrin injection. Light is transmitted from the laser to the tumor via quartz fiber optics (interstitial or surface PDT). Another bronchoscopy is performed 48 hours after PDT treatment to clean out any tissue debris left after PDT treatment. HDR brachytherapy is performed using prescribed dose of radiation for 5-10 minutes to designated positions. Repeat bronchoscopy is performed 3-4 weeks post HDR brachytherapy and a second HDR brachytherapy treatment may be given. Patients are followed every 3 months until death, or for 5 years.\n\nPROJECTED ACCRUAL: 16 patients will be entered over 1.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed small cell or non-small cell primary lung cancer with symptomatic endobronchial lesion(s) partially or totally obstructing airway distal to the carina and accessible by endoscopy Recurrent disease following prior therapy and/or be ineligible for, or refuse, alternative standard therapy such as: Surgery External radiation therapy Chemotherapy High grade obstruction necessitating more rapid aeration and palliation than standard therapy can provide No evidence of encasement or extension of the tumor to the right or left major pulmonary vessels on CT of the chest No tumor involvement at trachea or carina\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 times the upper limit of normal SGOT/SGPT less than 2 times the upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant Adequate method of contraception required of all fertile patients Female fertile patients must have normal serum beta HCG Not eligible for standard therapy and/or other protocol therapy No hypersensitivity to DHE or other porphyrins Not concurrent photosensitizing drugs such as: Tetracycline Doxorubicin No contraindications to general anesthesia, including EKG abnormalities suggestive of acute ischemia\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy within 3 weeks prior to study entry No doxorubicin within 8 weeks prior to study entry Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy dose no higher than 75 Gy to proposed bronchial segment allowed No concurrent external brain radiation therapy Surgery: Not specified'}, 'identificationModule': {'nctId': 'NCT00014066', 'briefTitle': 'Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Phase I Study of Photodynamic Therapy (PDT) Combined With High Dose Rate (HDR) Brachytherapy for Patients With Obstructive Bronchogenic Carcinoma', 'orgStudyIdInfo': {'id': 'DS 92-40'}, 'secondaryIdInfos': [{'id': 'RPCI-DS-92-40'}, {'id': 'NCI-V97-1190'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'hematoporphyrin derivative', 'type': 'DRUG'}, {'name': 'brachytherapy', 'type': 'RADIATION'}]}, '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': 'Gregory M. Loewen, DO, FCCP', 'role': 'STUDY_CHAIR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}}}}