ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma
30 de junho de 2015 atualizado por: Active Biotech AB
A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.
The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system.
This results in an accumulation of white blood cells in the cancer that can fight the cancer.
This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
526
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Pleven, Bulgária, 5800
- Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"
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Plovdiv, Bulgária, 4004
- 1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital
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Sofia, Bulgária, 1431
- Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology
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Sofia, Bulgária, 1527
- Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"
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Varna, Bulgária, 9002
- Urology Clinic, General Hospital for Active Treatment "St. Anna"
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Veliko Tarnovo, Bulgária, 5000
- Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital
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Arkhangelsk, Federação Russa
- Arkhangelsk Regional Oncology Center
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Chelyabinsk, Federação Russa, 454087
- Chelyabinsk Regional Oncology Center
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Kazan, Federação Russa, 420029
- Republican Clinical Oncology Center
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Kazan, Federação Russa, 420111
- Kazan City Oncology Center
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Moscow, Federação Russa, 115478
- Russian Oncological Research Center n.a. N.N. Blokhin
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Moscow, Federação Russa, 105425
- Research Institute of Urology
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Moscow, Federação Russa, 117997
- Russian Research Center of Radiology
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Obninsk, Federação Russa, 249036
- Medical Radiology Research Center
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Orenburg, Federação Russa, 460021
- Orenburg Regional Clinical Oncology Center
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St. Petersburg, Federação Russa, 191104
- Leningrad Regional Oncological Center
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St. Petersburg, Federação Russa, 193312
- Municipal Aleksandrovskaya Hospital
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St. Petersburg, Federação Russa, 194354
- Municipal Multi-Speciality Hospital #2
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St. Petersburg, Federação Russa, 196247
- Municipal Hospital #26
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St. Petersburg, Federação Russa, 197022
- Municipal Clinical Oncology Center
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St. Petersburg, Federação Russa, 197758
- Central Research Institute of Roentgenology and Radiology
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St. Petersburg, Federação Russa, 197758
- Research Institute of Oncology n.a. Professor N.N. Petrov
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St. Petersburg, Federação Russa, 198205
- Municipal Hospital #15
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Stavropol, Federação Russa, 355047
- Stavropol Territorial Clinical Oncology Center
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Yaroslavl, Federação Russa, 150054
- Regional Clinical Oncology Hospital
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Cambridge, Reino Unido, CB2 0QQ
- Addenbrooke's Hospital, Cambridge Clinical Trials Centre
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Derby, Reino Unido, DE1 2QY
- Derby Hospital NHS Trust
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Glasgow, Reino Unido, G12 0YN
- The Beatson West of Scotland Cancer Centre
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Leeds, Reino Unido, LS9 7TF
- St. James's Institute of Oncology
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London, Reino Unido, SW6 6JJ
- The Royal Marsden NHS Trust
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Manchester, Reino Unido, M20 4BX
- The Christie Hospital NHS Trust
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Swansea, Reino Unido, SA2 8QA
- South Wales Cancer Institute, Singleton Hospital
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Bucharest, Romênia, 022328
- Fundeni Clinical Institute - Urology Department
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Bucharest, Romênia, 041345
- Dinu Uromedica
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Bucharest, Romênia, 050659
- "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
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Cluj Napoca, Romênia, 400015
- "I. Chiricuta" Institute of Oncology
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Cluj Napoca, Romênia, 400016
- E-URO Medical Center
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Constanta, Romênia, 900635
- Provita Center SRL
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Sibiu, Romênia, 550245
- Sibiu Clinical Country Hospital - Urology Clinic
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Timisoara, Romênia, 300239
- Oncomed SRL
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Cherkassy, Ucrânia, 18009
- Cherkassy Regional Oncology Center
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Chernigov, Ucrânia, 14029
- Chernigov Regional Oncology Center
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Dnepropetrovsk, Ucrânia, 49005
- Urology Department, Dnepropetrovsk State Medical Academy
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Dnepropetrovsk, Ucrânia, 49102
- City General Hospital #4
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Donetsk, Ucrânia, 83092
- Donetsk Regional Antitumor Center
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Ivano-Frankovsk, Ucrânia, 76000
- Ivano-Frankovsk Regional Oncology Center
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Kharkiv, Ucrânia, 61037
- Kharkiv Regional Urology and Nephrology Center
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Kiev, Ucrânia, 04053
- Institute of Urology under the Academy of Medical Sciences of Ukraine, Department of Plastic and Supportive Urology
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Kiev, Ucrânia, 04053
- Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department
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Lvov, Ucrânia, 79031
- State Regional Diagnostics and Treatment Oncology Center
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Uzhorod, Ucrânia, 88014
- Regional Oncology Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Histologically or cytologically confirmed RCC (clear cell and papillary types)
- Metastatic or inoperable locally advanced RCC
- Eligible for therapy with IFN-alpha.
- Measurable disease defined by at least 1 measurable lesion on CT scan (lesion diameter greater than or equal to 2.0 cm by a standard CT scanner or greater than or equal to 1.0 cm by a spiral CT scanner)
- Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2)
- Karnofsky performance status greater than or equal to 70
- Age greater than or equal to 18
- Life expectancy greater than 3 months
Baseline blood counts:
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
- Platelets greater than or equal to 100 x 10^9/L
- Haemoglobin greater than or equal to 100 g/L
Baseline blood chemistry levels:
- Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
- Bilirubin less than or equal to 2 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. AST and ALT allowed less than or equal to 5 x ULN for patients with liver metastases.
- If fertile, patient will use effective method of contraception throughout the study
- Willing and able to comply with the treatment and follow-up visits and examinations
- Capable of understanding the parameters in the protocol and able to sign a written consent form
Exclusion Criteria:
- Pregnant or breastfeeding women
- Serious uncontrolled medical disorder or active infection ongoing or resolved within 2 weeks before first dose of study drug and that the investigator believes would impair the patient's ability to receive study drug
- History of malignancy within 5 years or concurrent malignancy, except successfully treated non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ or lobular carcinoma in situ of breast may be included
- History and/or signs of parenchymal brain metastases
- Significant cardiac disease including: history (within 6 months) or current unstable angina pectoris, congestive heart failure (NYHA stage III-IV), myocardial infarction within 12 months, or uncontrolled arterial hypertension.
- History of stroke within 5 years and/or transient ischemic attack within 6 months.
- Acute illness or evidence of infection, including unexplained fever (>100.5ºF or 38.1ºC) within 2 weeks before start of treatment
- Treatment with biological response modifiers within 3 weeks prior to the start of treatment and up to the End-of-Study visit
- Treatment with beta-blockers, including topical therapy for glaucoma, within 5 days before start of treatment and during the 4-day ABR-217620/naptumomab estafenatox treatment
- Treatment with systemic corticosteroids within 2 weeks before start of treatment or likely need for such treatment during the study
- Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis
- Known positive serology for HIV
- Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of chronic virus hepatitis or known virus carrying; patients who recovered from Hepatitis A are allowed
- Treatment with anticoagulants within 2 weeks before start of treatment, except when used to maintain the patency of a central or peripheral venous line
- Radiotherapy less than 4 weeks before start of treatment
- Major surgery or tumor embolization less than 4 weeks before start of treatment
- Previous exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins
- Currently on renal dialysis treatment
- Known allergy or hypersensitivity to aminoglycosides and kanamycin
- Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-alpha or IL-2 or any chemotherapy) except sunitinib or other oral antiangiogenic therapy
- Participation in any study with investigational drugs for RCC within 6 weeks
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 1
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10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
Outros nomes:
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Outros nomes:
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Experimental: Safety group
6-12 patients
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10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
Outros nomes:
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Outros nomes:
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Outro: 2
Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
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3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Time to death
Prazo: every 12 weeks, including after a maximum of 18 months of study treatment
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every 12 weeks, including after a maximum of 18 months of study treatment
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Progression-free survival time
Prazo: every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
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every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
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Objective tumor response rate
Prazo: every 12 weeks for the 18-month treatment period
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every 12 weeks for the 18-month treatment period
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Best overall response
Prazo: every 12 weeks for the 18-month treatment period
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every 12 weeks for the 18-month treatment period
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Duration of response
Prazo: every 12 weeks for the 18-month treatment period
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every 12 weeks for the 18-month treatment period
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Changes in sum of target lesions
Prazo: every 12 weeks for the 18-month treatment period
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every 12 weeks for the 18-month treatment period
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Immunological response in patients on combined treatment of ABR-217620/naptumomab estafenatox and IFN-alpha
Prazo: Weeks 1, 9, 17, 25, 73
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Weeks 1, 9, 17, 25, 73
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Vital signs
Prazo: every visit through Week 25, plus Week 73
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every visit through Week 25, plus Week 73
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Physical measurements
Prazo: Weeks 1, 9, 17, 25, 73
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Weeks 1, 9, 17, 25, 73
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Adverse events
Prazo: every visit through Week 73
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every visit through Week 73
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Laboratory safety assessments
Prazo: Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
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Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
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Pharmacokinetic parameters of ABR-217620/naptumomab estafenatox
Prazo: Weeks 1, 9, and 17
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Weeks 1, 9, and 17
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Thore Nederman, PhD, Active Biotech AB
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Hawkins RE, Gore M, Shparyk Y, Bondar V, Gladkov O, Ganev T, Harza M, Polenkov S, Bondarenko I, Karlov P, Karyakin O, Khasanov R, Hedlund G, Forsberg G, Nordle O, Eisen T. A Randomized Phase II/III Study of Naptumomab Estafenatox + IFNalpha versus IFNalpha in Renal Cell Carcinoma: Final Analysis with Baseline Biomarker Subgroup and Trend Analysis. Clin Cancer Res. 2016 Jul 1;22(13):3172-81. doi: 10.1158/1078-0432.CCR-15-0580. Epub 2016 Feb 5.
- Eisen T, Hedlund G, Forsberg G, Nordle Ö, Hawkins R. Baseline biomarker trend analysis of a randomized phase 2/3 study of naptumomab estafenatox plus IFN-α vs IFN-α in advanced renal cell carcinoma. European Cancer Congress (ECCO) 2013; Abstract ID: 2710.
- Elkord E, Burt DJ, Sundstedt A, Nordle O, Hedlund G, Hawkins RE. Immunological response and overall survival in a subset of advanced renal cell carcinoma patients from a randomized phase 2/3 study of naptumomab estafenatox plus IFN-alpha versus IFN-alpha. Oncotarget. 2015 Feb 28;6(6):4428-39. doi: 10.18632/oncotarget.2922.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2007
Conclusão Primária (Real)
1 de janeiro de 2013
Conclusão do estudo (Real)
1 de janeiro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
9 de janeiro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de janeiro de 2007
Primeira postagem (Estimativa)
11 de janeiro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
22 de julho de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de junho de 2015
Última verificação
1 de junho de 2014
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitais
- Neoplasias por local
- Doenças renais
- Doenças Urológicas
- Adenocarcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias Renais
- Carcinoma de Células Renais
- Carcinoma
- Efeitos Fisiológicos das Drogas
- Fatores imunológicos
- Anticorpos Monoclonais
- Imunoconjugados
Outros números de identificação do estudo
- 06762004
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .