Suspendido

A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease

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

bleomycin sulfate

+ dacarbazine

+ doxorubicin hydrochloride

BiológicoMedicamentoProcedimiento
Quiénes están siendo reclutados

Enfermedades hemáticas y linfáticas+6

+ Enfermedades del sistema inmunitario

+ Trastornos Inmunoproliferativos

De 15 a 65 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional
Inicio del estudio: abril de 2000
Ver detalles del protocolo

Resumen

Patrocinador PrincipalSWOG Cancer Research Network
Última actualización: 24 de enero de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de abril de 2000

Fecha en la que se inscribió al primer participante.

OBJECTIVES: Compare progression-free and overall survival of patients with stage III or IV Hodgkin's disease treated with doxorubicin, bleomycin, vinblastine, and dacarbazine with or without autologous peripheral blood stem cell transplantation and high-dose chemotherapy. Compare the toxic effects of these treatment regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of poor prognostic factors (3 vs 4 vs 5) and stage of disease (III vs IV). Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes, bleomycin IV over 10 minutes, vinblastine IV over 5 minutes, and dacarbazine IV over 15-30 minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients who show at least partial response after the fifth course of induction chemotherapy and whose blood counts have recovered are randomized to 1 of 2 treatment arms. Arm I: Patients receive 3 additional courses of induction chemotherapy for a total of 8 courses. Arm II: Patients receive 1 additional course of induction chemotherapy followed by stem cell collection. Patients then receive high-dose chemotherapy with carmustine IV over 2 hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. Patients undergo autologous peripheral blood stem cell transplantation on day 0. Patients are followed at 60 days, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.

NCT00005090
Patrocinador PrincipalSWOG Cancer Research Network
Última actualización: 24 de enero 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.
Detalles del Diseño

Se reclutarán 11 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

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.

De 15 a 65 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

Enfermedades hemáticas y linfáticasEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosEnfermedades LinfáticasTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológicoEnfermedad de HodgkinLinfoma

Criterios

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the following characteristics: Albumin less than 4.0 mg/dL Hemoglobin less than 10.5 g/dL Leukocytosis at least 15,000/mm^3 Lymphocytopenia less than 600/mm^3 or less than 8% of total WBC Male sex At least 45 years of age Stage IV disease Bidimensionally measurable disease Bilateral or unilateral bone marrow aspiration and biopsy performed within 42 days of study Negative chest x-ray within 42 days of study OR Chest x-ray performed within 28 days of study Negative CT scan of thorax, abdomen, and pelvis within 42 days of study OR CT scan of thorax, abdomen, and pelvis performed within 28 days of study No history of lymphoma, myelodyplastic syndrome, or leukemia No CNS involvement by Hodgkin's disease PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless elevation due to liver infiltration by Hodgkin's disease) Lymphoma-related hepatic dysfunction allowed Renal: Creatinine no greater than 2.0 times ULN Creatinine clearance at least 60 mL/min Lymphoma-related renal dysfunction allowed Cardiovascular: No coronary artery disease, cardiomyopathy, congestive heart failure, or arrhythmias requiring therapy Ejection fraction normal No significant EKG abnormalities suggesting active cardiac disease Pulmonary: Corrected DLCO at least 60% OR FEV1 at least 60% predicted Other: Not pregnant or nursing Fertile patients must use effective contraception No HIV or AIDS No other prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer No active bacterial, fungal, or viral infection* Afebrile for 3 consecutive days* NOTE: *Prior to randomization portion of study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease except single course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) within 35 days of study Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for Hodgkin's disease Surgery: Not specified Other: At least 3 days since prior antibiotics, antifungals, or antivirals (except for prophylactic therapy or fever associated with underlying lymphoma) (for randomization portion of study)

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Comparador Activo
Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m^2, bleomycin 10 U/m^2, vinblastine 6 mg/m^2, dacarbazine 375 mg/m^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.

Grupo II

Experimental
Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m^2, bleomycin 10 U/m^2, vinblastine 6 mg/m^2, dacarbazine 375 mg/m^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0.

Objetivos 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 47 ubicaciones

Veterans Affairs Medical Center - Birmingham

Birmingham, United StatesAbrir Veterans Affairs Medical Center - Birmingham en Google Maps

University of California San Diego Cancer Center

La Jolla, United States

Veterans Affairs Medical Center - San Francisco

San Francisco, United States

UCSF Cancer Center and Cancer Research Institute

San Francisco, United States
Suspendido47 Centros de Estudio