Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00002167
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012514', 'term': 'Sarcoma, Kaposi'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C063166', 'term': 'tin etiopurpurin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1999-04', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Skin Neoplasms', 'Sarcoma, Kaposi', 'Acquired Immunodeficiency Syndrome', 'Photochemotherapy', 'tin etiopurpurin', 'Radiation-Sensitizing Agents'], 'conditions': ['Sarcoma, Kaposi', 'HIV Infections']}, 'descriptionModule': {'briefSummary': "To determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT.", 'detailedDescription': 'All patients receive a single dose of SnET2 and are randomized to receive either PDT light treatment or no light treatment (control group). Patients are assessed prior to and at 4, 12 and 24 weeks following treatment, and are followed for 7 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* Documentation of at least one biopsy-confirmed KS lesion.\n* A minimum of 4 and no more than 36 KS lesions.\n* All eligible lesions must be bidimensionally measurable, treatable by surface (non-contact) light illumination, and \\<= 40 mm in diameter of the longest bidimensional axis.\n* ACTG disease state T(0) L(0) or (1) S(0) or (1).\n* Life expectancy greater than 6 months.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Active opportunistic infection or condition except thrush or herpes simplex virus infections.\n* Advanced KS tumor stages including the presence of tumor associated edema or ulceration, extensive oral KS, or KS in other non-nodal viscera.\n* Hematopoietic dysfunction.\n* Coagulation dysfunction.\n* Hepatic dysfunction.\n* Renal dysfunction.\n* Cardiovascular dysfunction - Presence of significant coronary artery disease requiring current treatment or myocardial infarction.\n* Pulmonary dysfunction.\n* Sepsis.\n* Known disorder of lipoprotein metabolism or clearance.\n\nPatients with the following prior conditions are excluded:\n\n* History of allergic or hypersensitivity reactions to light, egg proteins or egg yolks, history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.\n\nExcluded within 7 days of therapy:\n\n* Hematopoietic dysfunction.\n* Coagulation dysfunction.\n* Hepatic dysfunction.\n* Renal dysfunction.\n\nExcluded within 3 months of therapy:\n\n* Pulmonary dysfunction.\n\nExcluded within 6 months of therapy:\n\n* Myocardial infarction.\n\nPrior Medication:\n\nExcluded:\n\n* Intralesional chemotherapy within the past 12 weeks.\n* Systemic chemotherapy or investigational drugs within the past 4 weeks.\n\nPrior Treatment:\n\nExcluded within 3 months prior to therapy:\n\n* Local cryotherapy or surgery to study lesions.\n* Systemic or topical photodynamic therapy agents.'}, 'identificationModule': {'nctId': 'NCT00002167', 'briefTitle': "Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.", 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': "Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.", 'orgStudyIdInfo': {'id': '261A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tin ethyl etiopurpurin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Univ of Southern California / Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Med Ctr', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Univ of California / San Francisco / Dermatology', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Health One - Rocky Mountain Cancer Ctr', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Buffalo Gen Hosp / PDT Ctr', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '37916', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Thompson Cancer Survival Ctr', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Solutions', 'class': 'INDUSTRY'}}}}