Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: "Stanford V Regimen" For "Low Risk" Patients, "EBVP Regimen" For "High Risk" Patients
bleomycin sulfate
+ filgrastim
+ Stanford V regimen
Enfermedades hemáticas y linfáticas+6
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: Investigate the effects on survival, life expectancy and quality, toxicity, and immunological status in low risk patients with Hodgkin's Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin, bleomycin, vinblastine, and prednisone. OUTLINE: Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status (0-2 vs 3-4), presence or absence of AIDS before the diagnosis of Hodgkin's Disease, and immune status (CD4+ cell count greater vs no greater than 100/mm^3). Low risk patients (those with no risk factors) receive the EBVP regimen, as follows: Epirubicin intravenously on day 1 Bleomycin intramuscularly or intravenously on day 1 Vinblastine intravenously on day 1 Prednisone orally on days 1-5 Patients also receive daily injections of filgrastim (granulocyte colony-stimulating factor; G-CSF) on days 6-15. This schedule is repeated every 3 weeks for 6 courses. High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows: Doxorubicin and vinblastine intravenously on days 1 and 15 Mechlorethamine intravenously on day 1 Vincristine and bleomycin intravenously on days 8 and 22 Etoposide intravenously on days 15 and 16 Prednisone orally daily Patients also receive daily injections of G-CSF on days 3-7, 9-13, 17-21, and 23-26. This schedule is repeated every 28 days for 3 courses. Patients are followed every 2 months the first year and then every 3 months thereafter. PROJECTED ACCRUAL: 20-30 patients will initially be accrued in this study.
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 proven Hodgkin's disease: Clinical or pathologic stage II - IV Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms Confirmed HIV infection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-4 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: No severe neurologic or metabolic disease No concurrent or prior second malignancy except: Nonmelanomatous skin cancer In situ cancer of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No prior therapy for Hodgkin's disease Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
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
Centro di Riferimento Oncologico - Aviano
Aviano, ItalyAbrir Centro di Riferimento Oncologico - Aviano en Google Maps