Vaccine Therapy in Treating Patients With Metastatic Melanoma
Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial
RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma.
- Determine the longevity of melanoma-specific immunity in patients treated with this regimen.
- Perform serial analysis of T-cell and B-cell function in patients treated with this regimen.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation.
Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression.
Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Baylor University Medical Center
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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 metastatic melanoma
- HLA-A2-01 phenotype
- Measurable disease
- No active CNS or hepatic metastases
PATIENT CHARACTERISTICS:
Age:
- 21 and over
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- See Disease Characteristics
- No viral hepatitis
Renal:
- Not specified
Cardiovascular:
- No prior venous thrombosis, angina pectoris, or congestive heart failure
- Lactate dehydrogenase less than 2 times normal
Pulmonary:
- No prior asthma
Immunologic:
- Intradermal skin test positivity to mumps, Candida, or streptokinase antigen
- No known sensitivity to E. coli drug preparations
- No prior allergy to influenza vaccine
- No active infection
- No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis)
Other:
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 8 weeks since prior interleukin-2
- At least 4 weeks since prior interferon alfa
Chemotherapy:
- At least 8 weeks since prior chemotherapy
Endocrine therapy:
- At least 2 weeks since prior corticosteroids
- No concurrent corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent immunosuppressive agents
- At least 2 weeks since prior immunosuppressive agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Otros números de identificación del estudio
- CDR0000068680
- BAYUMC-000048
- NCI-4170
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