Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-28 @ 5:29 PM
Study NCT ID:
NCT00049959
Status:
TERMINATED
Last Update Posted:
2011-03-16
First Post:
2002-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D001478', 'term': 'Basal Cell Nevus Syndrome'}, {'id': 'C537656', 'term': 'Basal cell carcinoma, multiple'}], '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': 'D009807', 'term': 'Odontogenic Cysts'}, {'id': 'D007570', 'term': 'Jaw Cysts'}, {'id': 'D001845', 'term': 'Bone Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'statusVerifiedDate': '2011-03', 'dispFirstSubmitDate': '2011-03-01', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-01', 'studyFirstSubmitDate': '2002-11-15', 'dispFirstSubmitQcDate': '2011-03-01', 'studyFirstSubmitQcDate': '2002-11-18', 'dispFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Verteporfin PDT', 'multiple basal cell carcinoma', 'nevoid basal cell carcinoma syndrome'], 'conditions': ['Basal Cell Carcinoma', 'Nevoid Basal Cell Carcinoma Syndrome', 'Gorlin Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.', 'detailedDescription': "Basal cell carcinoma (BCC) of the skin is the most common type of cancer that can be treated with various therapies including surgical removal. A number of factors can lead to the development of multiple BCC of the skin, including genetic disorders (e.g., nevoid basal cell carcinoma syndrome). Treatment of multiple BCC becomes much more challenging. In these trials, the experimental therapy: verteporfin PDT is compared to placebo PDT. PDT or photodynamic therapy in these studies is the combination of the photoactive drug verteporfin (given intravenously) and red light exposure of skin tumors.\n\nThe primary objective is to assess whether verteporfin PDT can completely eliminate multiple BCCs. Eligible subjects will have at least 3 BCCs. Study subjects won't know which treatment they have been been assigned to - this is done randomly (like flipping a coin). After study treatment, the BCCs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment. Safety will be assessed by testing blood samples before and after study treatment, and analyzing adverse events and skin reactions to the study treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently has at least 3 eligible BCC skin tumors that have never been treated\n* Is willing to have these tumor sites surgically removed\n\nExclusion Criteria:\n\n* Has xeroderma pigmentosum\n* Has BCC tumors that are the result of prior radiotherapy or immunosuppression due to an organ transplant\n* Is immunosuppressed\n* Has abnormal liver function\n* Is receiving systemic chemotherapy or has received chemotherapy within the last two years'}, 'identificationModule': {'nctId': 'NCT00049959', 'briefTitle': 'Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.', 'organization': {'class': 'INDUSTRY', 'fullName': 'QLT Inc.'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Masked, Multicenter Phase III Study Of Photodynamic Therapy With Verteporfin For Injection (VFI) For The Treatment Of Multiple Basal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'VFI MBCC 01 and VFI MBCC 02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'verteporfin PDT', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Herma Neyndorff', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QLT Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QLT Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}]}}}