A Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20 Positive Non-Hodgkin's Lymphoma (NHL): Combining 90-Yttrium- Zevalin and the Redox- Modulating Agent, Motexafin Gadolinium (MGd)
Rituxan
+ motexafin gadolinium
+ 111Indium-Zevalin and 90Yttrium-Zevalin
Enfermedades hemáticas y linfáticas+6
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Estudio de Tratamiento
Resumen
Fecha de inicio: 28 de octubre de 2003
Fecha en la que se inscribió al primer participante.This is a phase I, dose-escalation study of motexafin gadolinium followed by a phase II study. Patients are stratified according to extent of lymphomatous involvement (≤ 5% vs > 5 but ≤ 24% of cellular elements). Cohorts of 3-6 patients in each stratum receive escalating doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity (DLT) OR the dose preceding that at which 2 of 3 or 3 of 6 patients experience DLT. * Once the MTD is determined, additional patients are treated at that dose level as in phase I. Patients are followed weekly for 3 months and then monthly for 5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 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 diagnosis of one of the following: * Low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) * The following histologies are eligible: * Small lymphocytic lymphoma * Lymphoplasmacytoid lymphoma * Follicular center grades 1, 2, or 3 lymphoma * Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type * Nodal marginal zone B-cell lymphoma * Relapsed or refractory after 2 prior treatment regimens or 1 anthracycline regimen * Diffuse large B-cell NHL or mantle cell lymphoma in first or second relapse * Transformed NHL, defined as low-grade NHL transformed to diffuse large B-cell lymphoma, with no more than 1 relapse since transformation Age 18 and over Recovered from prior immunotherapy Life expectancy At least 3 months Recovered from prior chemotherapy * More than 4 weeks since prior major surgery and recovered * More than 4 weeks since prior anticancer therapy recovered from prior radiotherapy Exclusion criteria: No major bleeding within the past 4 weeks No uncontrolled hypertension No stroke within the past 4 weeks * No active infection * No other active nonmalignant disease * No known G6PD deficiency * No history of porphyria * No other condition that would preclude study participation * No human anti-mouse antibodies * No known history of HIV * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior radioimmunoconjugate therapy * No prior exposure to murine antibodies other than rituximab * More than 4 weeks since prior rituximab * No history of failed stem cell collection
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 2 ubicaciones
Jesse B. Brown Veterans Affairs Medical Center
Chicago, United States