A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
rituximab
Enfermedades hemáticas y linfáticas+5
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab. Secondary * Determine the progression-free and overall survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of rituximab off study at the discretion of the treating physician. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-9 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 12 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.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 confirmed primary CNS lymphoma based on 1 of the following: * Histologically confirmed non-Hodgkin's B-cell lymphoma by brain biopsy or resection * Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease * Histologically confirmed vitreal lymphoma with measurable intracranial tumor * CD20 positive by brain biopsy * Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI * Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment * No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast * No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry * No ocular lymphoma by slit lamp examination PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic * Bilirubin less than 1.5 mg/dL * Transaminases less than 4 times upper limit of normal Renal * Creatinine less than 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after study participation * HIV negative * Mini mental status examination score at least 15 * No concurrent serious infection * No other medical illness that would preclude study treatment * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy * More than 90 days since prior biologic therapy * No prior rituximab * No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 months since prior radiotherapy Surgery * Not specified Other * Recovered from prior therapy * More than 90 days since prior investigational drugs * More than 90 days since prior use of a therapeutic device
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 9 ubicaciones
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, United StatesAbrir Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham en Google MapsH. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, United StatesWinship Cancer Institute of Emory University
Atlanta, United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United States