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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01592617
Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer
Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.
The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to standard therapy.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Shiga
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Otsu, Shiga, Japão, 520-2192
- Department of Medical Oncology, Shiga University of Medical Science Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Advanced NSCLC that cannot undergo curative surgery.
- Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
- Histologically diagnosed NSCLC.
- Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
- ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
- Life expectancy > 3 months.
- Age between 20 to 79
- Male or Female.
- In patients or out patients.
- Able and willing to give valid written informed consent.
Exclusion Criteria:
- Other malignancy requiring treatment
- radiation, immunotherapy, hyperthermia, or surgery.
- Active and uncontrolled infectious disease
- Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
- Autoimmune disease.
- HIV-Ab or antigen positive
- Prior anti-cancer therapy within 4 weeks
- Laboratory values as follows: 2000<mm3 < WBC < 15000/mm3, Platelet count < 50000/mm3, Asparate transaminase > 5 X cutoff value, Alanine transaminase > 5 X cutoff value, Total bilirubin > 3 X cutoff value, and Serum creatinine > 3X cutoff value.
- Patients knows HLA-A type.
- Breastfeeding and Pregnancy (woman of child bearing potential)
- Refusal of pregnancy conception.
- Treated with S-488401, S-488402, or S-488403.
- Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
- Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: S-488410
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In multicenter HLA-blinded open study, patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.
Prazo: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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CTL response between HLA-A24:02 and non-HLA-A24:02
Prazo: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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PFS and ORR between HLA-A24:02 and non-HLA-A24:02
Prazo: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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PFS and OS between CTL response positive and negative
Prazo: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence
Prazo: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Identification of biomarkers for efficacy and safety that are mentioned above
Prazo: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14.
- Mizukami Y, Kono K, Daigo Y, Takano A, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Detection of novel cancer-testis antigen-specific T-cell responses in TIL, regional lymph nodes, and PBL in patients with esophageal squamous cell carcinoma. Cancer Sci. 2008 Jul;99(7):1448-54. doi: 10.1111/j.1349-7006.2008.00844.x. Epub 2008 Apr 30.
- Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.
- Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243.
- Harao M, Hirata S, Irie A, Senju S, Nakatsura T, Komori H, Ikuta Y, Yokomine K, Imai K, Inoue M, Harada K, Mori T, Tsunoda T, Nakatsuru S, Daigo Y, Nomori H, Nakamura Y, Baba H, Nishimura Y. HLA-A2-restricted CTL epitopes of a novel lung cancer-associated cancer testis antigen, cell division cycle associated 1, can induce tumor-reactive CTL. Int J Cancer. 2008 Dec 1;123(11):2616-25. doi: 10.1002/ijc.23823.
- Daigo Y, Nakamura Y. From cancer genomics to thoracic oncology: discovery of new biomarkers and therapeutic targets for lung and esophageal carcinoma. Gen Thorac Cardiovasc Surg. 2008 Feb;56(2):43-53. doi: 10.1007/s11748-007-0211-x. Epub 2008 Feb 24.
- Hayama S, Daigo Y, Kato T, Ishikawa N, Yamabuki T, Miyamoto M, Ito T, Tsuchiya E, Kondo S, Nakamura Y. Activation of CDCA1-KNTC2, members of centromere protein complex, involved in pulmonary carcinogenesis. Cancer Res. 2006 Nov 1;66(21):10339-48. doi: 10.1158/0008-5472.CAN-06-2137.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- S488410LP
- UMIN000007873 (Identificador de registro: UMIN: University Hospital Medical Information Network)
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 .
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