Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00007969
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2001-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C112124', 'term': 'detox adjuvant'}, {'id': 'D000077362', 'term': 'Verteporfin'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2001-01-06', 'studyFirstSubmitQcDate': '2004-03-10', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage III melanoma', 'stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy may be effective in treating melanoma.\n\nPURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy in treating patients who have stage III or stage IV melanoma.', 'detailedDescription': 'OBJECTIVES: I. Determine the safety of photodynamic therapy with verteporfin and Detox-B adjuvant in patients with stage III or IV melanoma. II. Determine the clinical response in patients treated with this regimen. III. Determine whether this regimen induces systemic cellular and humoral immune responses to melanoma antigens in these patients. IV. Determine the ablation of cutaneous tumors in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study. Patients undergo photodynamic therapy with verteporfin and Detox-B adjuvant. Treatment repeats every 2 weeks for a total of 3 courses, each to a different melanoma lesion. Both non-treated and treated tumors are measured prior to study and at months 2, 4, and 6. Immune profile is also assessed prior to study and at months 2, 4, and 6.\n\nPROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Diagnosis of stage III or IV melanoma At least 3 cutaneous tumors for treatment (treatment tumors) AND 1-7 additional cutaneous, visceral, or lymph node tumors for response assessment (marker tumors) Treatment tumors must be on trunk, arms, or legs AND be 1.0-3.6 cm in longest dimension Measurable disease by calipers or CT scan No CNS metastases by CT scan\n\nPATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 2,500/mm3 Neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 9 g/dL Hematocrit at least 27% Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST/ALT no greater than 2 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 2 times ULN\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: No concurrent surgical removal of melanoma lesions designated for treatment or response assessment Other: No other concurrent therapy for melanoma'}, 'identificationModule': {'nctId': 'NCT00007969', 'briefTitle': 'Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant Melanoma', 'orgStudyIdInfo': {'id': 'CDR0000068358'}, 'secondaryIdInfos': [{'id': 'QLT-VFI-PDV-01'}, {'id': 'QLT-PHO-VFI-PDV-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Detox-B adjuvant', 'type': 'BIOLOGICAL'}, {'name': 'verteporfin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80010', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Comprehensive Cancer Center at Aventura', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Comprehensive Cancer Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '48201-1379', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Baptist Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '15213-3489', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Graeme R. Boniface, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'QLT Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QLT Inc.', 'class': 'INDUSTRY'}}}}