- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00104780
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Phase II, Open Label, Multi-center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Compare the overall survival of patients with HLA-A2-positive, stage IIIB or IV or recurrent non-small cell lung cancer (NSCLC) treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative, stage IIIB or IV or recurrent NSCLC who undergo observation only.
- Determine the safety of this vaccine in these patients.
Secondary
- Determine progression-free survival of patients treated with this vaccine.
- Determine the frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine.
OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status.
- Group I (HLA-A2 positive): Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15.
- Group II (HLA-A2 negative): Patients undergo observation in weeks 9 and 18. After completion of study treatment, patients in group I are followed at 3 weeks. All patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Ocoee, Florida, Estados Unidos, 34761
- Cancer Centers of Florida - Ocoee
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New York
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Albany, New York, Estados Unidos, 12208
- New York Oncology Hematology, P. C. at Albany Regional Cancer Care
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Kettering, Ohio, Estados Unidos, 45409
- Dayton Oncology & Hematology, P.A. - Kettering
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- Cancer Centers of the Carolinas - Eastside
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Cancer Center at Centennial Medical Center
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Mary Crowley Medical Research Center at Sammons Cancer Center
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Tyler, Texas, Estados Unidos, 75702
- Tyler Cancer Center
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Washington
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Spokane, Washington, Estados Unidos, 99218
- Cancer Care Northwest - North
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:
- Stage IIIB disease
- Stage IV disease
- Recurrent disease
HLA-A2-positive disease
- HLA-A2 negative patients are eligible to enroll in group II (observation) only
- Measurable disease
- Estimated tumor volume ≤ 125 cc
No CNS signs or symptoms of brain metastases
- Brain metastases that are clinically stable for ≥ 2 months AND do not require anticonvulsants or systemic steroids are allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 12 weeks
Hematopoietic
- Hemoglobin ≥ 10 g/dL
- Platelet count > 100,000/mm^3
- WBC > 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Absolute lymphocyte count > 500/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver involvement by tumor)
- Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL for patients with liver involvement by tumor)
- Albumin ≥ 2.5 g/dL
- Alkaline phosphatase ≤ 2.5 times ULN
- No history of hepatitis B or C positivity
Renal
- Creatinine ≤ 2 times ULN
Immunologic
No history of any of the following active conditions:
- Systemic lupus erythematosus
- Scleroderma
- Connective tissue disease
- Sjögren's syndrome
- Multiple sclerosis
- Rheumatoid arthritis
- Inflammatory bowel disease
- No history of HIV positivity
- No history of serious adverse reaction, including anaphylaxis, or hypersensitivity to study vaccine or to any of its components
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 weeks after completion of study treatment
- No other malignancy within the past 5 years except curatively excised nonmelanoma skin cancer or surgically cured carcinoma in situ of the cervix
- No other acute medical condition that would preclude study treatment
- No mental or psychiatric condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 1 month since prior interferon therapy
- More than 1 month since prior interleukin therapy
- No prior cancer vaccine therapy, including participation in a vaccine study
Chemotherapy
- At least 4 weeks since prior chemotherapy
Endocrine therapy
- See Disease Characteristics
- More than 1 month since prior systemic corticosteroids except stable doses of inhaled corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- No concurrent participation in another investigational study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
---|
La seguridad
|
Comparison of overall survival with historical controls
|
Medidas de resultado secundarias
Medida de resultado |
---|
Supervivencia libre de progresión
|
Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Scott Plasman, Epimmune
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Efectos fisiológicos de las drogas
- Factores inmunológicos
- Adyuvantes, Inmunológicos
- Adyuvante de Freund
Otros números de identificación del estudio
- CDR0000415721
- EPIMMUNE-EP2101-201
- MCMRC-0461
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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