Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-29 @ 7:59 AM
Study NCT ID:
NCT00747903
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2008-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000622', 'term': 'Aminolevulinic Acid'}], 'ancestors': [{'id': 'D007982', 'term': 'Levulinic Acids'}, {'id': 'D007651', 'term': 'Keto Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2008-09-05', 'studyFirstSubmitQcDate': '2008-09-05', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety'}, {'measure': 'Efficacy'}]}, 'conditionsModule': {'keywords': ['basal cell carcinoma of the skin', 'recurrent skin cancer'], 'conditions': ['Non-melanomatous Skin Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment against skin cancer.\n\nPURPOSE: This phase II trial is studying the side effects of photodynamic therapy using aminolevulinic acid and to see how well it works in treating patients with skin cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To determine the safety and efficacy of intralesional photodynamic therapy using aminolevulinic acid and non-coherent blue light in patients with nodular basal cell carcinoma.\n\nOUTLINE: Patients undergo photodynamic therapy comprising intralesional injection of aminolevulinic acid followed by non-coherent blue light therapy over approximately 17 minutes. Patients may undergo re-treatment with photodynamic therapy 8 weeks later.\n\nPatients undergo photographic assessment of their skin lesions at baseline, 8 weeks, 16 weeks, and then at 1 and 2 years to evaluate healing time, clinical improvement, and side effects.\n\nPatients undergo biopsies of their skin lesions at 16 weeks and then at 1 and 2 years to confirm histological clearance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Biopsy-proven basal cell carcinoma on the trunk or extremities\n\n * Tumor size ≤ 2 cm in diameter\n\nPATIENT CHARACTERISTICS:\n\n* Willing and able to comply with all follow-up requirements\n* Mentally competent\n* No active, localized, or systemic infections\n* Not immunocompromised\n* No coagulation disorder\n* No photosensitivity or allergy to sunlight\n* Not pregnant or nursing\n* No history of keloid formation\n* No history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior gold therapy\n* No prior radiotherapy to the trunk and extremities\n* More than 24 months since prior oral retinoids (e.g., isotretinoin or acitretin) or photosensitizing drugs (e.g., Declomycin®)\n* More than 1 year since prior collagen or other injections, Botox® injections, chemical peels, dermabrasion, or resurfacing procedures\n* More than 1 month since prior topical retinoid therapy\n* No concurrent aspirin or antioxidants\n* No concurrent anticoagulation medications'}, 'identificationModule': {'nctId': 'NCT00747903', 'briefTitle': 'Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000613601'}, 'secondaryIdInfos': [{'id': 'DUSA-PDT-BCC-06'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aminolevulinic acid hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roy G. Geronemus, MD', 'role': 'CONTACT', 'email': 'mail@laserskinsurgery.com', 'phone': '212-686-7306'}], 'facility': 'Laser and Skin Surgery Center of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Diana Santanello', 'affiliation': 'Laser and Skin Surgery Center of New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laser and Skin Surgery Center of New York', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Roy G. Geronemus', 'oldOrganization': 'Laser and Skin Surgery Center of New York'}}}}