Rituximab Anti-CD20 Monoclonal Antibody and Dexamethasone in the Treatment of Relapsed Indolent Lymphoma
rituximab
+ dexamethasone
Trastornos de las Proteínas Sanguíneas+21
+ Enfermedades Cardiovasculares
+ Enfermedad Crónica
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the toxic effects of rituximab and dexamethasone in patients with recurrent or refractory indolent non-Hodgkin's lymphoma. II. Determine the objective tumor response rate and duration of response at 2 months after initiation of therapy, and the percentage of patients with progressive disease. III. Determine the maximum response, duration of response, and progression free interval for patients who have not progressed after 4 weeks of therapy. IV. Determine the failure-free and overall survival of these patients on this regimen. V. Compare the response rate and survival rates to results for similar patients (historical and concurrent) who have received 4 weeks of rituximab without dexamethasone, and patients who did not receive maintenance rituximab. OUTLINE: Patients receive dexamethasone IV followed by rituximab IV on days 1, 8, 15, and 22 for one course. Two months after initiating treatment, patients are evaluated for disease progression. Patients with stable or responding disease may receive monthly dexamethasone and rituximab therapy for up to 10 additional months. Patients are followed every 3 months for 2 years, then every 6 months for years 3-4, and then yearly for up to 5 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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.A partir de 18 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 proven stage III or IV, recurrent or refractory, indolent B cell non-Hodgkin's lymphoma of the following types: Working Group Formulation A (small cell lymphocytic) Working Group Formulation B, C, and D (follicular) Must have relapsed after prior chemotherapy At least 1 lymph node or visceral lesion at least 2 cm in diameter PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection HIV negative No hepatitis B or C No concurrent life threatening condition PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy for lymphoma (e.g., rituximab) Chemotherapy: See Disease Characteristics Endocrine therapy: No other concurrent corticosteroids and/or epinephrine (unless anaphylactic shock) Radiotherapy: Not specified Surgery: Not specified
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 3 ubicaciones
Hoag Memorial Hospital Presbyterian
Newport Beach, United StatesAbrir Hoag Memorial Hospital Presbyterian en Google MapsCancer Care Center for Southern Indiana
Bloomington, United StatesSt. Joseph Regional Cancer Center
Bryan, United States