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Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

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

Vinblastine sulfate

+ Dacarbazine
+ Filgrastim
Medicamento
Quiénes están siendo reclutados

HIV Infections

+ Hodgkin's Disease
A partir de 12 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 27 de octubre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response. Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle. All patients receive four cycles of treatment and are then restaged. Patients with a complete response (CR) following the initial four cycles receive two additional cycles of ABVD / G-CSF. Patients with a partial response following the initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged; those who have achieved a CR at that point then receive two more cycles, while those without CR discontinue study therapy. Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is administered.

Título OficialPhase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 27 de octubre de 2021
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 27 pacientesNúmero 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 sexoSexo biológico de los participantes elegibles para inscribirse.
A partir de 12 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Hodgkin's Disease
Criterios

Inclusion Criteria Concurrent Medication: Required: * PCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone. Recommended: * Antiemetic therapy within 30 minutes of chemotherapy. Allowed: * Antiretroviral medication after two cycles of chemotherapy, provided the patient has not experienced grade 3 neutropenia while on chemotherapy or on previous antiretroviral therapy. * Acetaminophen and/or nonsteroidal anti-inflammatory agents. * Bone marrow-suppressive agents, such as ganciclovir, Fansidar, Bactrim, and dapsone. * Maintenance therapy for chronic opportunistic infection. Concurrent Treatment: Allowed: * Cranial irradiation (2400 rads) for patients with CNS involvement. Patients must have: * Documented HIV infection or diagnosis of AIDS. * Hodgkin's disease. * Consent of parent or guardian and have care directly supervised by a pediatric oncologist if under 18 years of age. Prior Medication: Allowed: * Maintenance therapy for opportunistic infections. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Second primary cancer other than Kaposi's sarcoma that does not require systemic therapy, nonmelanomatous skin cancer, Bowen's disease, or carcinoma in situ of the cervix. * Acute, active bacterial or opportunistic infection requiring ongoing therapy if such therapy has been initiated within the past 2 weeks. * Known hypersensitivity (e.g., anaphylactoid reaction, bronchospasm) to E. coli-derived proteins. Prior Medication: Excluded: * Prior chemotherapy for Hodgkin's disease. * Antiretroviral therapy within 2 weeks prior to study entry. Prior Treatment: Excluded: * Prior radiotherapy for Hodgkin's disease.



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 8 ubicaciones
Suspendido
Alabama Therapeutics CRSBirmingham, United StatesVer ubicación
Suspendido
USC CRSLos Angeles, United States
Suspendido
Northwestern University CRSChicago, United States
Suspendido
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, United States

Completado8 Centros de Estudio