- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00045357
Biological Therapy in Treating Patients With Metastatic Melanoma
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and reinfusing them may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of autologous CD4+ antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the duration of in vivo persistence of adoptively transferred CD4+ antigen-specific T-cell clones in these patients.
Secondary
- Determine the antitumor effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo leukapheresis to collect peripheral blood mononuclear cells. CD4+ antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic peptides MART1, tyrosinase, or gp100.
Patients receive autologous CD4+ antigen-specific T-cells IV over 30 minutes.
Cohorts of 3-6 patients receive escalating doses of autologous CD4+ antigen-specific T-cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed on days 1 and 3 post T-cell infusion, and then once weekly for 12 weeks.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98109-1024
- Fred Hutchinson Cancer Research 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 type expressing one of the following class II alleles:
- DRB1*0401
- DRB1*0404
- DRB1*1501
- DPB1*0401
- DPB1*0402
- Tumor expresses tyrosinase
- Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed
No CNS metastases
- Prior CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after treatment
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- Karnofsky 70-100%
Life expectancy
- More than 16 weeks
Hematopoietic
- WBC greater than 4,000/mm^3
- Absolute neutrophil count greater than 2,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hematocrit greater than 30%
Hepatic
- SGOT no greater than 3 times upper limit of normal
- INR no greater than 1.5 due to hepatic dysfunction
- No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater
Renal
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 60 mL/min
- Calcium no greater than 12 mg/dL
Cardiovascular
No significant cardiac abnormalities*, defined by any 1 of the following:
- Congestive heart failure
- Clinically significant hypotension
- Symptoms of coronary artery disease
- Cardiac arrhythmias present on EKG requiring drug therapy NOTE: *Patients with a history of cardiovascular disease or any of the above abnormalities undergo a cardiac evaluation, including a cardiac stress test and/or echocardiogram
Pulmonary
- No clinically significant pulmonary dysfunction
- FEV1 at least 1.0 L OR
- FEV1 at least 60%
- DLCO at least 55% (corrected for hemoglobin)
Immunologic
- No acquired or hereditary immunodeficiency
- No autoimmune disease
- No active infection
- No oral temperature greater than 38.2 degrees C within the past 72 hours
- No systemic infection requiring chronic maintenance or suppressive therapy
- HIV negative
Other
- No retinitis or choroiditis
- No history of seizures
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer therapy)
Chemotherapy
- At least 4 weeks since prior chemotherapy (standard or experimental) and recovered
Endocrine therapy
- No concurrent systemic steroids except for toxicity management
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- At least 4 weeks since prior immunosuppressive therapy
- More than 4 weeks since prior experimental drugs and recovered
- No concurrent pentoxifylline
- No other concurrent investigational 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
Finalización del estudio (Actual)
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
- 1585.00
- FHCRC-1585.00
- NCI-H02-0093
- CDR0000256867 (Identificador de registro: PDQ)
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