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Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line Chemotherapy

14 de setembro de 2017 atualizado por: University of Miami

Phase I/II Clinical Trial of Immunotherapy With an Allogeneic B7.1/HLA-A1 Transfected Tumor Cell Vaccine in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer That Have Completed First Line Chemotherapy

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung cancer who have finished first-line chemotherapy.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

OUTLINE: This is a multicenter study.

  • Phase I (single site [University of Miami Sylvester Comprehensive Cancer Center]): Patients receive allogeneic B7.1 and human leukocyte antigen-A1 (HLA-A1) transfected tumor cell vaccine intradermally (ID) in weeks 1, 3, and 5. Treatment repeats every 6 weeks for 2 courses. If no more than 1 of 6 patients experience a probable or definitively treatment related adverse effect (i.e., grade 2 autoimmune or grade 3-4 of any type), patients proceed to the phase II portion of the study. If 2 or more (out of 6) patients experience treatment related adverse effects the study stops.

  • Phase II (randomized): Patients are stratified according to study site (University of Miami Sylvester Comprehensive Cancer Center or Memorial Regional Hospital), type of prior first-line treatment (platinum and taxane vs platinum and gemcitabine), and presence of brain metastasis (yes vs no). Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive allogeneic B7.1 and HLA-A1 transfected tumor cell vaccine ID in weeks 1, 3, and 5. Treatment repeats every 6 weeks for 2 courses.
    • Arm II: Patients receive a placebo vaccine as in arm I. Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for cluster of differentiation 8 (CD8), cluster of differentiation 4 (CD4), and natural killer cell (NK) response and peripheral blood lymphocytes (PBL) and T helper cell 1 (TH1)/T helper cell 2 (TH2) bias, including levels of interleukin (IL) IL-1β, IL-2, IL-4, IL-5, IL-6, IL-13, Interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α) via ELISA.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 4 years, and then once a year thereafter.

PROJECTED ACCRUAL: A total of 66 patients (6 patients for phase I and 60 patients for phase II) will be accrued for this study.

Tipo de estudo

Intervencional

Inscrição (Real)

1

Estágio

  • Fase 2
  • Fase 1

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

  • Estados Unidos
    • Florida
      • Hollywood, Florida, Estados Unidos, 33021
        • Memorial Regional Hospital
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami Sylvester Comprehensive Cancer Center

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

  • Patients with stage IIIB (non-candidates for radiation) or stage IV pathologically confirmed non-small cell carcinoma of the lung that completed 4-6 cycles of platinum based first line chemotherapy and achieved complete response (CR), partial response (PR) or stable disease.
  • Last administration of chemotherapy occurred no later than 4 weeks prior to the enrollment date.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min.

  • Pulmonary Function Requirements:

    • All patients will undergo evaluation of pulmonary function prior to enrollment.
    • Patients should have a Forced expiratory volume in 1 second (FEV1) more than 30% of the predicted value and/or Diffusing capacity (DLCO) more than 30% of the predicted value with a partial pressure of carbon dioxide (PCO2) < 45mm.
    • Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, congestive heart failure (CHF) or pulmonary embolism (PE)) will have request pulmonary function test (PFT) evaluation and if the above parameters are seen will be excluded from the protocol.
  • Age ≥ 18 years.
  • Signed informed consent.
  • Patients should have absolute neutrophil count (ANC) ≥ 1000/mm3; platelets (PLT) ≥ 80,000/mm3.

EXCLUSION CRITERIA:

  • Small cell carcinoma of the lung.
  • Existing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease etc; colitis, inflammatory bowel disease or pancreatitis within 10 years of study.
  • Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
  • Concomitant steroid or other immunosuppressive therapy.
  • Active infection, or less than 7 days since therapy for acute infections.
  • Pericardial effusion.
  • Currently receiving chemotherapy for another condition (such as arthritis).
  • Time elapsed greater than 4 weeks since last administration of first line chemotherapy for NSCLC.
  • Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction.
  • Pregnant or lactating women (negative test for pregnancy required of women of childbearing potential).
  • Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
  • Known HIV infection
  • Untreated or uncontrolled brain metastasis.
  • Liver Enzymes greater than 3 times the institutional upper limit.

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: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm I: Allogeneic B7.1/HLA-A1

Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.

Given intradermally.
Biológico: Allogeneic B7.1/HLA-A1
Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally
Outros nomes:
  • - B7.1
  • - B7
  • - Ad100-B45-Neo-B7.1-HLA A1 or HLA2
Comparador de Placebo: Arm II: Placebo
Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.
Outro: Placebo
Given intradermally

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Preliminary Safety Profile (Phase 1)
Prazo: Up to 13 weeks
This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.
Up to 13 weeks
Progression-free Survival (Phase 2)
Prazo: Date of randomization to the earliest date of documented progression.
Date of randomization to the earliest date of documented progression.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2)
Prazo: About 13 weeks
Rate of immune response (CD8) in B-7 vaccinated participants reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses.
About 13 weeks
Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2)
Prazo: From Week 1 of Study Therapy until Death or Withdrawal of Consent
Relationship of CD8 response in B7-vaccinated patients to their progression-free survival. Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact).
From Week 1 of Study Therapy until Death or Withdrawal of Consent
Safety Profile (Phase 2)
Prazo: About 13 weeks
The rate of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.
About 13 weeks
Response to Second-line Chemotherapy After Disease Progression (Phase 2)
Prazo: From Week 1 of Study Therapy until Death or Withdrawal of Consent
The percentage of patients experiencing a clinical response (complete response (CR), partial response (PR), stable disease (SD)) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls.
From Week 1 of Study Therapy until Death or Withdrawal of Consent
Overall Survival (Phase 2)
Prazo: Date of randomization to the recorded date of death
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that study participants are still alive.
Date of randomization to the recorded date of death
Correlative Immunological Studies in Study Participants (Phase 2)
Prazo: Baseline, Week 7 and Week 13
The time course of patients' adaptive immune response to B7 vaccination as compared to control vaccine will be characterized by their CD8, CD4, and NK response (measured by ELI-spots for interferon-gamma (IFN-γ), interleukin 4 (IL-4), and granzyme B secretion) measured prior to vaccination (i.e. at baseline) and over two courses of vaccination (measurements at week 7 and 13).
Baseline, Week 7 and Week 13

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Miami

Investigadores

  • Cadeira de estudo: Luis E. Raez, MD, FACP, University of Miami Sylvester Comprehensive Cancer Center

Publicações e links úteis

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Publicações Gerais

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 (Real)

1 de janeiro de 2009

Conclusão Primária (Real)

1 de abril de 2010

Conclusão do estudo (Real)

1 de abril de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

20 de setembro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de setembro de 2007

Primeira postagem (Estimativa)

24 de setembro de 2007

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de outubro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de setembro de 2017

Última verificação

1 de setembro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 20057158
  • SCCC-2005042 (Outro identificador: UM/Sylvester Comprehensive Cancer Center)
  • WIRB-20051678 (Outro identificador: Western IRB (WIRB))

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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