Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
filgrastim
+ therapeutic allogeneic lymphocytes
+ cyclophosphamide
Enfermedades Urogenitales+16
+ Adenocarcinoma
+ Carcinoma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation in patients with metastatic renal cell carcinoma or melanoma. Determine the incidence and severity of all adverse events related to this treatment regimen in this patient population. Determine the efficacy of this treatment regimen in terms of tumor regression, response duration, progression free survival, and overall survival in these patients. Measure the resulting chimerism and immune reconstitution in these patients after this treatment regimen and correlate with clinical response. OUTLINE: Patients receive fludarabine IV over 30 minutes on days -8 through -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Immediately following each daily donor leukapheresis, patients receive allogeneic peripheral blood stem cells (PBSC) IV over 15 minutes beginning on day 0 and continuing until the target cells are collected. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover. If no graft versus host disease has developed within 4 weeks of allogeneic PBSC transplantation, patients with disease progression or recurrence who have residual donor hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes. Patients may receive an additional course of donor T lymphocytes at the investigator's discretion. Patients are followed at days 30 and 100, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 10-38 patients will be accrued for this study within 2.5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 19 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma or melanoma that is not potentially curable by surgery Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI Measurable disease by radiography must be reproducible Bony disease or effusions not measurable No active CNS disease currently receiving radiotherapy or steroids No effusion or ascites of more than 1 liter prior to drainage HLA 5/6 or 6/6 matched sibling donor available No known hypersensitivity to E. coli derived products No active infection No health condition that would preclude donation PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 g/dL No active hepatitis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF at least 50% Pulmonary: DLCO at least 50% of predicted Other: No active infection HIV negative No psychological problem that would preclude study compliance No known hypersensitivity to E. coli derived products Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior systemic chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
University of Chicago Cancer Research Center
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