Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00044356
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2002-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Trial of Allovectin-7® for Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C096492', 'term': 'Allovectin-7'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-05', 'studyFirstSubmitDate': '2002-08-26', 'studyFirstSubmitQcDate': '2002-08-27', 'lastUpdatePostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Melanoma', 'Metastatic Melanoma', 'Malignant Melanoma', 'Skin Cancer', 'Tumor', 'Experimental Treatment', 'Clinical Trial', 'Gene Therapy', 'Gene Delivery', 'Gene Transfer', 'Immunotherapy', 'Cancer', 'Neoplasm', 'Lesion', 'Metastasis', 'Cancerous mole', 'Melanoma vaccine', 'Cancer research', 'Cancer cells', 'Allovectin-7®'], 'conditions': ['Melanoma', 'Metastatic Melanoma', 'Malignant Melanoma', 'Skin Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.', 'detailedDescription': "Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.\n\n* You have been diagnosed with Stage III or Stage IV melanoma\n* Your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or you refused therapy with standard treatment\n* You are able to carry out your normal daily activities\n* Your melanoma has not spread to your brain'}, 'identificationModule': {'nctId': 'NCT00044356', 'briefTitle': 'Phase II Trial of Allovectin-7® for Metastatic Melanoma', 'nctIdAliases': ['NCT00028444'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Vical'}, 'officialTitle': 'A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'VCL-1005-208'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Allovectin-7®', 'type': 'GENETIC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas Cancer Research Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '48202', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Blood and Cancer Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80010', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology Specialists, S.C.', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21236', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Hematology Oncology Associates of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55422', 'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'facility': 'North Memorial Health Care', 'geoPoint': {'lat': 45.03219, 'lon': -93.33856}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Melanoma Center of Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dmitri D. Kharkevitch, MD, PhD', 'oldOrganization': 'Vical Incorporated'}}}}