A Pilot Study of Peripheral Blood Stem Cell Transplantation (PBSCT) After Preparative Therapy Consisting of Cyclophosphamide, BCNU, and Etoposide (CBV) for Recurrent and Primarily Refractory Hodgkin's and Non-Hodgkin's Lymphoma
carmustine
+ cyclophosphamide
+ etoposide
Infecciones por virus ADN+17
+ Enfermedades hemáticas y linfáticas
+ Infecciones por Herpesviridae
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Estimate the failure-free survival rate in a cohort of relapsed Hodgkin's lymphoma and non-Hodgkin's lymphoma patients after retrieval therapy which includes peripheral blood stem cell transplantation (PBSCT) in patients who achieve a complete remission or partial remission. Estimate the post complete/partial remission failure-free survival rate in these patients. Characterize the time to recovery of normal bone marrow function after transplantation in these patients. OUTLINE: Patients receive 2 courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement is still present at harvest, then 2 additional courses of induction chemotherapy are given. The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course, consisting of the following: Carmustine IV over 3 hours on days -8, -7, and -6 Etoposide continuous IV over days -8, -7, and -6 Cyclophosphamide IV over 1 hour daily on days -5, -4, -3, and -2 Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3, 6, 9, and 12 hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to protect lungs from the toxic effects of carmustine. PROJECTED ACCRUAL: A total of 30 patients will be accrued in each subgroup.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 69 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 1 a 21 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 non-Hodgkin's lymphoma in first relapse or refractory after primary induction therapy Histologically confirmed Hodgkin's lymphoma in first relapse after chemotherapy with more than one nodal region involved at relapse or refractory after primary induction therapy (i.e., failed to achieve remission at the conclusion of standard induction chemotherapy) No prior radiotherapy only for low stage nodal disease No greater than 4 courses of standard chemotherapy for low stage nodal disease CSF or bone marrow involvement at time of study entry is allowed PATIENT CHARACTERISTICS: Age: 1 to 21 (at initial diagnosis) Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: SGOT or SGPT less than 2.5 times normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Glomerular filtration rate greater than 60 mL/min as measured by radionuclide scan or 24 hour urine collection for creatinine clearance Cardiovascular: Shortening fraction of at least 28% by echocardiogram Ejection fraction of at least 40% by radionuclide angiogram echocardiogram Pulmonary: Total lung capacity (TLC) at least 50% OR Vital capacity (VC) at least 65% of normal DLCO at least 55% of normal For children who are uncooperative to pulmonary function testing, no dyspnea at rest or with mild exercise, and a pulse oximetry of at least 95% Other: HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
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
Objetivos Secundarios
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 235 ubicaciones
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesAbrir University of Alabama at Birmingham Comprehensive Cancer Center en Google MapsUniversity of South Alabama Medical Center
Mobile, United StatesPhoenix Children's Hospital
Phoenix, United StatesArizona Cancer Center
Tucson, United States