- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00050323
Safety/Efficacy of a Vaccine Prepared From Dendritic Cells Combined With Tumor Cells to Treat Advanced Kidney Cancer
Phase 1/2 Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusion in Patients With AJCC Stage IV Renal Cell Carcinoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Approximately 30,000 new cases of kidney cancer will be diagnosed in the U.S. in 2002, with renal cell carcinoma (RCC) being the most commonly diagnosed type. For patients with locally advanced or metastatic disease, the treatment options are extremely limited and additional options are warranted. Although RCC is generally considered resistant to chemotherapy, spontaneous regressions in patients with metastatic disease have led to research involving immune-mediated therapeutic approaches. Clinical responses have been observed and additional immune-modulating therapeutics are being studied.
Several such approaches have used dendritic cells (DCs), which are known to be potent antigen presenting cells. An antigen is a protein that, when shown to the immune system in the right way, can trigger the cells of the immune system to recognize, remember and eliminate other cells that also display that specific antigen. The cancerous cells in tumors present antigens in such a way that the body's immune system often fails to recognize and eliminate them. It is theorized that when DCs are fused to tumor cells the resulting fused cells will be capable of presenting tumor antigens in an enhanced manner, thus allowing the body's immune system to recognize the tumor antigens on the cancer itself. If this occurs, the patient's immune system may be specifically stimulated, producing a clinically meaningful immune response against the tumor.
In this study DCs produced from healthy volunteer donors (allogeneic DCs) will be fused to the patient's own tumor cells (autologous tumor cells), using an electrical current. The fused dendritic/tumor cells will be returned to the patient in a series of vaccines, six weeks apart.
The purpose of this trial is to determine whether fusing autologous tumor with allogeneic DCs will, with limited associated toxicity, present tumor antigen in such a way as to stimulate an immune response and also show evidence of tumor response.
Tipo de estudio
Inscripción
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Estados Unidos, 02215
- Dana Farber Cancer Institute (DFCI)
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The patient must be greater than or equal to 18 years of age.
- The patient must be diagnosed with AJCC Stage IV (primary or relapsed) Renal Cell Carcinoma.
- The patient must have a Screening Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status of 0-1.
- The patient must have accessible tumor (minimum of 2.5 cm in diameter in aggregate and accessible as defined in the clinical protocol) for vaccine production.
- The patient must have measurable tumor lesions (using Response Evaluation Criteria in Solid Tumors [RECIST]) following resection of tumor lesion(s) used for vaccine production. If the patient has received previous radiation or intra-tumoral investigational treatments, the measurable disease must be outside the previous radiation port or treatment area unless there is documented tumor progression following the completion of therapy.
- The patient must have adequate hematologic, hepatic, and renal function parameters at Screening: White blood cell (WBC) count greater than or equal to 3,000 cells/mm3; Platelet count greater than or equal to 100,000 platelets /mm3; Creatinine (serum) less than 2.0 mg/dL; Total bilirubin less than 2.0 mg/dL; Serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) less than 2.0 x Upper limits of normal; Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) less than 2.0 x Upper limits of normal
- The patient must be serologically negative for human immunodeficiency virus (HIV)-1, HIV-2, and human T lymphotropic virus (HTLV)-1.
- Female patients of childbearing potential must have negative pregnancy tests, refrain from nursing and must agree to use appropriate contraception for the duration of the trial.
- The patient must have signed and dated written informed consent prior to any study procedures. The consent process must be documented in the patient's medical record.
Exclusion Criteria:
- The patient has received prior chemotherapy for the treatment of RCC.
- The patient has received more than 2 prior regimens for treatment of RCC and the most recent is within 2 weeks of the first screening procedure.
- The patient has received radiation therapy within 2 weeks of the first screening procedure.
- The patient has a clinically significant autoimmune disorder.
- The patient has an active infection at the time of the first screening procedure requiring parenteral antibiotics.
- The patient has clinically significant hematologic, cardiac, renal, or hepatic disease or any other underlying condition that would contraindicate study therapy or confuse interpretation of study results.
- The patient has a history of more than one brain metastasis. Patients with a history of a single brain metastasis must have completed definitive treatment for this metastasis not less than 12 weeks prior to the time of first screening procedure and have remained clinically stable during this interval.
- The patient has a previous unrelated malignancy or second malignancy within 5 years prior to the first screening procedure, except for non-melanoma skin cancer and in situ carcinomas.
- The patient is receiving chronic immunosuppressive and/or oral steroid treatment.
- The patient has any other reason in the Investigator's opinion that would make protocol compliance unmanageable or may compromise the patient's ability to give informed consent.
- The patient has been treated with a non-oncologic investigational drug, biologic or medical device within 30 days of the first screening procedure.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DCREN-005-01
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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