Suspendido

Phase II Study of High-Dose Cytarabine, Cisplatin, and Dexamethasone Followed By Cyclophosphamide, Etoposide, Total Body Irradiation, and Autologous Bone Marrow Rescue in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

cisplatin

+ cyclophosphamide

+ cytarabine

MedicamentoProcedimientoRadiación
Quiénes están siendo reclutados

Enfermedad Crónica+21

+ Infecciones por virus ADN

+ Enfermedades Hematológicas

A partir de 16 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: marzo de 1990
Ver detalles del protocolo

Resumen

Patrocinador PrincipalSt. Luke's Medical Center
Última actualización: 18 de diciembre de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de marzo de 1990

Fecha en la que se inscribió al primer participante.

OBJECTIVES: I. Determine the toxicity and activity of cyclophosphamide, etoposide, total body irradiation, and autologous bone marrow transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma. II. Determine the feasibility of pretransplantation cytoreduction with a regimen of high-dose cytarabine, cisplatin, and dexamethasone in this patient population. III. Determine the feasibility of posttransplantation radiotherapy given to sites of residual disease (involved-field "boost" irradiation) in this patient population. OUTLINE: Patients are stratified by disease status (refractory vs relapsed). Autologous bone marrow is harvested before cytoreduction or involved field radiotherapy (IFRT). Patients with marrow involvement who achieve marrow complete response after cytoreduction undergo harvest of bone marrow before IFRT. Patients receive cytoreduction comprising high-dose cytarabine IV over 1 hour every 12 hours, cisplatin IV over 10 hours, and dexamethasone three times daily on days 1 and 2. At 3 weeks, a second course is administered if tumor reduction is at least 25% and in the absence of unacceptable toxicity. Patients with involved sites 2 cm or greater in diameter at evaluation and previously unirradiated active disease sites, at least 90% of which can be treated with IFRT, undergo IFRT 5 days a week for 2 weeks beginning after cytoreduction and 3-5 weeks after harvest of bone marrow. Within 10 days after completion of IFRT, patients receive etoposide IV over 26 hours beginning on day -7, cyclophosphamide IV over 2 hours on days -6 to -4, and total body irradiation twice daily on days -3 and -2 and once on day -1. Bone marrow is reinfused on day 0. Eligible patients with residual disease at 3 months after transplantation undergo involved field "boost" irradiation to sites of residual disease. PROJECTED ACCRUAL: Approximately 50 patients (25 per stratum) will be accrued for this study.

NCT00002481
Patrocinador PrincipalSt. Luke's Medical Center
Última actualización: 18 de diciembre de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 16 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

Enfermedad CrónicaInfecciones por virus ADNEnfermedades HematológicasEnfermedades hemáticas y linfáticasInfecciones por HerpesviridaeEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosInfeccionesLeucemiaLeucemia LinfocíticaEnfermedades LinfáticasTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológicoProcesos PatológicosCondiciones Patológicas, Signos y SíntomasInfecciones por Virus TumoralesEnfermedades ViralesLeucemia de células BLinfoma de BurkittLinfomaLinfoma FolicularLinfoma no HodgkinLeucemia linfocítica crónica de células B

Criterios

DISEASE CHARACTERISTICS: Histologically proven or unequivocal radiologic evidence of non-Hodgkin's lymphoma that has relapsed or is refractory after first-line chemotherapy Unequivocal radiologic evidence of relapse defined as the presence of enlarged (at least 2 cm diameter) lymph nodes by CT scan or lymphangiogram Biopsy of accessible lymph nodes to confirm relapse encouraged Low-, intermediate-, or high-grade disease Normal bilateral bone marrow biopsy at time of bone marrow collection required (cellularity at least 20% and no histologic evidence of tumor) History of marrow involvement allowed if present marrow is histologically normal No disease progression in a previously irradiated site A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 16 and over Performance status: CALGB 0-2 Karnofsky 70-100% Life expectancy: More than 2 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 times normal SGOT and SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal Hepatitis B surface antigen negative Renal: Creatinine normal Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac ejection fraction normal by MUGA scan No uncontrolled or severe cardiovascular disease, including the following: Myocardial infarction within the past 6 months Congestive heart failure Symptomatic angina (despite optimal medical management) Life-threatening arrhythmia or hypertension Pulmonary: Pulmonary function tests (DLCO and spirometry) greater than 60% predicted Other: HIV negative No serious organ dysfunction (unless caused by lymphoma) No active bacterial, viral, or fungal infection No active peptic ulcer disease No uncontrolled diabetes mellitus No other malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No other serious medical or psychiatric illness that would preclude study Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior nitrosourea allowed if cumulative dose no more than 600 mg/m2 Prior bleomycin allowed if cumulative dose no more than 300 units/m2 Prior doxorubicin allowed if cumulative dose no more than 450 mg/m2 No prior high-dose etoposide (more than 1,800 mg/m2) No prior high-dose cyclophosphamide (more than 100 mg/kg) No chemotherapy within 4 weeks (no melphalan, nitrosourea, or mitomycin within 6 weeks) prior to bone marrow collection No prior salvage therapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to liver or lung Prior other radiotherapy allowed if doses do not exceed the following limits: 1,400 cGy to the mediastinum 1,400 cGy to the whole abdomen 4,000 cGy to the CNS 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 una ubicación

St. Luke's Medical Center

Milwaukee, United StatesAbrir St. Luke's Medical Center en Google Maps
Suspendido1 Centros de Estudio