Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease
filgrastim
+ cyclophosphamide
+ etoposide
Enfermedades hemáticas y linfáticas+6
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease. Assess the feasibility and toxic effects of CECP in this patient population. OUTLINE: Patients receive oral lomustine on day 1, oral etoposide on days 1-3, and oral cyclophosphamide and procarbazine on days 22-31. Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42. The course is repeated every 6 weeks. Patients with a complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy. Patients failing to respond after 1 course are removed from the study. Patients will be followed every 3 months until death. PROJECTED ACCRUAL: A minimum of 16 evaluable patients will be accrued.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 5 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.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically proven stage IIB-IV AIDS-related Hodgkin's disease Patients with Hodgkin's disease as the only HIV-related condition must have a positive ELISA for HIV confirmed by Western Blot Measurable or evaluable disease No cytologic or radiologic evidence of CNS involvement PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-3 Life expectancy: At least 6 weeks Hematopoietic: WBC at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Other: Active infection is allowed (provided prognosis is estimated to be at least 6 weeks) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease At least 4 weeks since chemotherapy for Kaposi's sarcoma Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy for localized stage I or II disease that has progressed beyond initial radiation ports is allowed Surgery: Not specified Other: Concurrent AZT therapy is allowed
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
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
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, United StatesAbrir Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center en Google Maps