Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-27 @ 9:54 PM
Study NCT ID:
NCT00518895
Status:
COMPLETED
Last Update Posted:
2011-11-07
First Post:
2007-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], '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': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'C408162', 'term': 'oblimersen'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-04', 'studyFirstSubmitDate': '2007-08-14', 'studyFirstSubmitQcDate': '2007-08-17', 'lastUpdatePostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival and overall survival', 'timeFrame': 'Every 42 days from date of randomization during protocol therapy'}], 'secondaryOutcomes': [{'measure': 'Response rate, durable response rate, duration of response, safety', 'timeFrame': 'Response and progression every 42 days from date of randomization during protocol therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Melanoma', 'Advanced Melanoma', 'Malignant Melanoma', 'Metastatic Melanoma', 'Skin Cancer', 'Genasense', 'oblimersen', 'antisense', 'Bcl-2 antisense', 'G3139', 'dacarbazine'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 [Abstract T-26].'}, {'pmid': '16966688', 'type': 'BACKGROUND', 'citation': 'Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. doi: 10.1200/JCO.2006.06.0483. Epub 2006 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of melanoma\n* Progressive disease that is not surgically resectable, or metastatic Stage IV\n* Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal\n* No prior chemotherapy\n* Measurable disease\n* ECOG performance status ≤ 1\n* At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy\n* Prior immunotherapy allowed\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment\n* Primary ocular or mucosal melanoma\n* Bone-only metastatic disease\n* History or presence of brain metastasis or leptomeningeal disease\n* Significant medical disease other than cancer\n* Organ allograft'}, 'identificationModule': {'nctId': 'NCT00518895', 'acronym': 'AGENDA', 'briefTitle': 'Trial of Dacarbazine With or Without Genasense in Advanced Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genta Incorporated'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)', 'orgStudyIdInfo': {'id': 'AGENDA'}, 'secondaryIdInfos': [{'id': 'GM307'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Dacarbazine with Genasense', 'interventionNames': ['Drug: dacarbazine plus Genasense']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Dacarbazine with placebo', 'interventionNames': ['Drug: dacarbazine plus placebo']}], 'interventions': [{'name': 'dacarbazine plus Genasense', 'type': 'DRUG', 'otherNames': ['dacarbazine plus Genasense (oblimersen, G3139)'], 'description': "Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense group will receive Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.", 'armGroupLabels': ['A']}, {'name': 'dacarbazine plus placebo', 'type': 'DRUG', 'otherNames': ['dacarbazine plus placebo (0.9% Sodium Chloride Injection)'], 'description': "Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus placebo group will receive placebo (that is, locally available commercial 0.9% Sodium Chloride Injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.", 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Hospital, Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Pacific Oncology and Hematology Associates Inc.', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Redwood Regional Medical Group, Inc.', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology Oncology Associates', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Hematology Oncology Centers of the Northern Rockies', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Memorial - Atlantic Healthcare System', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates, Site 1', 'geoPoint': {'lat': 36.15398, 'lon': 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