- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00503568
Vaccine Therapy in Treating Patients With Stage III, Stage IV, or Relapsed Non-Small Cell Lung Cancer Treated With First-Line Chemotherapy
Novel Tumor Vaccine gp96-Ig Fusion Protein in Advanced (Stage IIIB), Relapsed or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed First Line Chemotherapy
RATIONALE: Vaccines made from a person's tumor cells may help the body build an effective immune response to kill non-small cell lung cancer cells.
PURPOSE: This phase I trial is studying the effects of gp96-Ig vaccine therapy in treating patients with stage III, stage IV, or relapsed non-small cell lung cancer treated with first-line chemotherapy.
Visão geral do estudo
Descrição detalhada
Overall Goals:
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
- to evaluate the safety of administering a heat shock protein gp96-Ig-secreting allogeneic tumor cell-vaccine (gp96-Ig vaccine) in patients with advanced NSCLC.
Secondary Aims:
- to study the immune response to vaccination,
- to monitor clinical responses and
- to recommend a dose-schedule combination for further testing in an initial Phase II trial of vaccine efficacy.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Florida
-
Miami, Florida, Estados Unidos, 33136
- University of Miami Sylvester Comprehensive Cancer Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria
- Histologically confirmed NSCLC (squamous, adeno-, large cell anaplastic, bronchoalveolar, and non-small cell carcinoma NOS): stage IIIB with malignant pleural effusion, stage IV, or recurrent disease.
- At least one site of bi-dimensionally measurable disease.
- Metastasis if present and treated must be stable by CT scan or MRI for at least 8 weeks.
- Patient must have received and failed at least one line of chemotherapy.
- Age >= 18 years.
- ECOG performance status 0-2.
- Life expectancy >= 3 months.
Laboratory parameters:
- Hemoglobin levels >= 10.0 (transfusions allowed if necessary).
- ANC >= 1,500.
- Platelets >= 100k.
- Creatinine clearance >= 50 ml/min.
- Total and direct bilirubin: < 2.5 X upper institution limit for normal.
- Liver function tests: AST, ALT, and AlkP < 2.5 X upper institution limit for normal.
- Signed informed consent.
- Autopsy consent - although not a requirement for study entry, patients who consent to participate in study will be made aware of the critical importance of a post-mortem examination in the event of the patient's death after receiving therapy with this experimental vaccine. Therefore, pre-treatment written agreement to autopsy will be sought from the patient, or verbal agreement to autopsy will be sought in the presence of the next of kin or other family members.
Exclusion Criteria
- Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction. Patients with history of these conditions who are stable taking cardiac medications will also be excluded.
- Pregnant or lactating women (negative test for pregnancy is required of women of childbearing potential).
- Known HIV infection.
- Uncontrolled or untreated brain or spinal cord metastases.
- Active infection.
- Concomitant steroid or other immunosuppressive therapy.
- Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
- Alcohol or chemical abuse.
- Meningeal carcinomatosis.
- Chemotherapy, radiation therapy, or other anti-tumor therapy during the last four weeks.
- Prior biologic response modifier therapy.
- Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
- Immune deficiency syndromes, including the following: rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, glomerulonephritis.
Compromised lung function:
- FeV1 < 30% of the predicted value, or
- DLCO < 30% of the predicted value, or
- PCO2 > 45 mmHg.
- Any patient enrolled on study whose respiratory symptoms have experienced marked deterioration not related to a known cause, such as pneumonia, congestive heart failure, or pulmonary embolism, will have a repeat PFT evaluation, and if the above parameter values for FeV1, DLCO, or PCO2 are seen, will be excluded from further treatment.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: DS-1: gp96-ig Dose Schedule 1
Dose Schedule 1 (DS-1): Ad100-gp96Ig-HLA A1 Vaccine 4x10^7 cells bi-weekly, maximum 9 vaccines/patient;
|
Dose Schedule 1 (DS-1): 4x10^7 cells bi-weekly, maximum 9 vaccines/patient; Dose Schedule 2 (DS-2): 2X10^7 cells weekly, maximum 18 vaccines/patient; Dose Schedule 3 (DS-3): 1x10^7 cells twice weekly, maximum 36 vaccines/patient
Outros nomes:
|
Experimental: DS-2: gp96-ig Dose Schedule 3
Dose Schedule 2 (DS-2): Ad100-gp96Ig-HLA A1 Vaccine 2X10^7 cells weekly, maximum 18 vaccines/patient;
|
Dose Schedule 1 (DS-1): 4x10^7 cells bi-weekly, maximum 9 vaccines/patient; Dose Schedule 2 (DS-2): 2X10^7 cells weekly, maximum 18 vaccines/patient; Dose Schedule 3 (DS-3): 1x10^7 cells twice weekly, maximum 36 vaccines/patient
Outros nomes:
|
Experimental: DS-3: gp96-ig Dose Schedule 3
Dose Schedule 3 (DS-3): Ad100-gp96Ig-HLA A1 Vaccine 1x10^7 cells twice weekly, maximum 36 vaccines/patient
|
Dose Schedule 1 (DS-1): 4x10^7 cells bi-weekly, maximum 9 vaccines/patient; Dose Schedule 2 (DS-2): 2X10^7 cells weekly, maximum 18 vaccines/patient; Dose Schedule 3 (DS-3): 1x10^7 cells twice weekly, maximum 36 vaccines/patient
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Safety
Prazo: 6, 12, 18, 24, and 36 months post enrollment
|
6, 12, 18, 24, and 36 months post enrollment
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Immunologic response: CD8, CD4 and NK response
Prazo: Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19
|
Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Luis E. Raez, MD, FACP, University of Miami Sylvester Comprehensive Cancer Center
Publicações e links úteis
Publicações Gerais
- Raez LE, Cassileth PA, Schlesselman JJ, Sridhar K, Padmanabhan S, Fisher EZ, Baldie PA, Podack ER. Allogeneic vaccination with a B7.1 HLA-A gene-modified adenocarcinoma cell line in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2800-7. doi: 10.1200/JCO.2004.10.197.
- Raez LE, Podack ER, CD8 T cell response in a phase I study of therapeutic vaccination of advanced NSCLC with allogeneic tumor cells secreting endoplasmic reticulum-chaperone gp96-Ig-peptide complexes. Advances in Lung Cancer 2(1): 9-18, 2013 doi:10.4236/alc.2013.21002
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- 20020225
- SCCC-2002041 (Outro identificador: UM/Sylvester Comprehensive Cancer Canter)
- WIRB-20050969 (Outro identificador: Western IRB)
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 .
Ensaios clínicos em Câncer de pulmão
-
University of LorraineConcluídoCriança, Somente | Pneumotórax espontâneo | Pneumotórax idiopático | Bleb LungFrança
-
Assiut UniversityAinda não está recrutandoCâncer de pulmão | Lesão pulmonar | Bleb Lung
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
-
Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
-
Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos
Ensaios clínicos em Ad100-gp96Ig-HLA A1
-
Eckhard PodackRetiradoCâncer de Pulmão de Células Não Pequenas | NSCLC | Câncer de pulmão | Carcinoma Pulmonar de Células Não Pequenas
-
Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)Concluído