A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older
Colección de datos
Enfermedades del sistema inmunitario+5
+ Trastornos Inmunoproliferativos
+ Enfermedades Linfáticas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation. Secondary * Determine the overall survival of patients treated with this regimen. * Determine the toxicity and tolerability of this regimen in these patients. OUTLINE: * Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until day -4. * Autologous stem cell transplantation: Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning on day 0 and continuing until blood counts recover. Patients are followed at 1, 3, 6, and 12 months and then annually thereafter. PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 25 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 60 a 80 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 * CD20+ disease * Failed at least 1 prior standard systemic therapy * Persistent lymphoma by physical examination, radiographic studies, bone marrow evaluations, flow cytometry, or polymerase chain reaction * Tumor burden less than 500 cc by computed tomography or MRI * No splenomegaly * Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved * No circulating lymphoma cells by morphology or flow cytometry at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be used * 10% or less marrow involvement by flow cytometry or morphology if purged bone marrow is to be used * No CNS lymphoma * No chronic lymphocytic leukemia or small lymphocytic lymphoma/well-differentiated lymphocytic lymphoma PATIENT CHARACTERISTICS: Age * 60 to 80 Performance status * SWOG 0-1 Life expectancy * More than 60 days Hematopoietic * See Disease Characteristics Hepatic * Bilirubin less than 1.5 mg/dL Renal * Creatinine less than 2.0 mg/dL Cardiovascular * No active coronary artery disease Pulmonary * FEV_1 at least 70% of expected * Vital capacity at least 70% of expected Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * Able to perform self-care during radiation isolation * No major organ dysfunction * No major infection * No circulating anti-mouse antibody * No other serious medical condition considered to represent contraindications to bone marrow transplantation * No competing causes of death that would predict life span to be less than 10 additional years PRIOR CONCURRENT THERAPY: Biologic therapy * No prior bone marrow or stem cell transplantation Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or more than 25% of red marrow) Surgery * Not specified Other * More than 30 days since prior systemic antilymphoma therapy
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos 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