Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-03-21 @ 10:54 AM
Study NCT ID:
NCT01743157
Status:
COMPLETED
Last Update Posted:
2013-08-29
First Post:
2011-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab for Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
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'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D007376', 'term': 'Interleukin-2'}, {'id': 'D007438', 'term': 'Introns'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D021901', 'term': 'DNA, Intergenic'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'nctId': 'NCT00495066', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2011-04-04', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)', 'timeFrame': 'Primary Objective', 'description': 'Determine the incidence of grade 4 bevacizumab-related toxicities and grade 3 proteinuria when bevacizumab is given with biochemotherapy to patients with metastatic melanoma for up to 3 years.'}], 'secondaryOutcomes': [{'measure': 'A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)', 'timeFrame': 'Secondary Objective', 'description': 'Compare median and overall progression-free survival to previously published historical control group of 135 patients receiving biochemotherapy followed by pulse IL-2, and also patients in the study of Weber et al (Reference 9) of ipilimumab in previously untreated patients for up to 4 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Melanoma']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '3. Minor DR, Wang W, Kashani-Sabet: Concurrent bevacizumab (BEV) with biochemotherapy (BIO) followed by ipilimumab for advanced melanoma: a phase I-II trial. J Clin Onc 2013 (suppl; abstr e200001)'}]}, 'descriptionModule': {'briefSummary': 'A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).', 'detailedDescription': 'A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy (Temodar,Cisplatin, Velban,IL2 and IFN)plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stage 4 or unresectable stage 3 metastatic melanoma with or without measurable disease\n2. Age 18-70 years old\n3. Adequate pulmonary and cardiac function for high-dose IL-2\n4. PS 0-2\n5. Previous ipilimumab therapy will not exclude patients, but patients with previous ipilimumab will have separate efficacy analysis\n\nExclusion Criteria:\n\n1. Brain metastases\n2. Creatinine \\> 2x ULN; bilirubin \\> 3, WBC \\< 3500, Platelets \\< 100,000, Hgb \\< 9\n3. Another active malignancy\n4. Gastrointestinal tract metastases except rectal metastases or primary are allowable\n5. Previous therapy for metastatic disease with chemotherapy of duration over 3 months or with high-dose interleukin-2\n6. History of colitis or autoimmune disease such as lupus or rheumatoid arthritis\n7. Bevacizumab-related contraindications: Hemoptysis or history of severe bleeding, uncontrolled hypertension, proteinuria with protein/creatinine ratio \\> 1, acute myocardial infarction within 6 months'}, 'identificationModule': {'nctId': 'NCT01743157', 'acronym': 'BBI', 'briefTitle': 'Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab for Metastatic Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'California Pacific Medical Center Research Institute'}, 'officialTitle': 'A Phase I-II Study of Treatment of Metastatic Melanoma Using Induction Therapy With Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab (BBI)', 'orgStudyIdInfo': {'id': 'BBI Total Therapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biochemo + Bevacizumab then Ipilimumab', 'description': 'Single arm: Biochemotherapy with 4 cycles at 3 week intervals of Temozolamide 150mg/m2 x4, cisplatin 20mg/m2 x 4, vinblastine 1.2mg/m2 x 4, bevacizumab 7.5-15 mg/kg x 1, interferon 5mg/m2 x5 and aldesleukin 36,18,9, % 9 miu/day over 4 days each cycle; then ipilimumab 3mg/kg q 21 days x 4, then q 3 months x 8 for total 3 years.', 'interventionNames': ['Drug: Biochemo + bevacizumab then ipilimumab']}], 'interventions': [{'name': 'Biochemo + bevacizumab then ipilimumab', 'type': 'DRUG', 'otherNames': ['Avastin,', 'Temodar,', 'Platinol,', 'Velban,', 'interleukin-2,', 'Intron-A,', 'Yervoy'], 'description': 'Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, \\& 4)', 'armGroupLabels': ['Biochemo + Bevacizumab then Ipilimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Oncology Associates', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'David R Minor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Pacific Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Pacific Medical Center Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'David Minor, MD', 'investigatorAffiliation': 'California Pacific Medical Center Research Institute'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-03-16', 'type': 'RELEASE'}, {'date': '2015-03-25', 'type': 'RESET'}, {'date': '2016-07-25', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2016-07-28', 'type': 'RELEASE'}, {'date': '2016-09-14', 'type': 'RESET'}, {'date': '2024-08-21', 'type': 'RELEASE'}, {'date': '2024-09-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'David Minor, MD, Medical Doctor, California Pacific Medical Center Research Institute'}}}}