Completado

Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma

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

Filgrastim

+ Vincristine sulfate
+ Doxorubicin hydrochloride
Medicamento
Quiénes están siendo reclutados

Lymphoma, Non-Hodgkin

+ HIV Infections
A partir de 16 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 1 de noviembre de 2012
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population. Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma. Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma. Patients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day 1. Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation. G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until blood counts have recovered to an acceptable level. Patients with evidence of cancer cells in their cerebrospinal fluid (CSF) will receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of cancer cells is found in the CSF, then once weekly for 6 weeks, and then monthly for 10 months. Seven to ten days following completion of one cycle of chemotherapy, patients undergo radiotherapy to the brain at a dose of 2.5 Gy daily for 5 days per week for approximately 4 weeks. Total dose to the whole brain and meninges is 30.0 Gy in 12 fractions, and total dose to the primary boost volume is 10.0 Gy in 4 fractions. During therapy, blood is drawn weekly and brain scans are performed every 3-12 weeks. An initial CSF sample will be obtained by lumbar puncture.

Título OficialPhase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 1 de noviembre de 2012
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 33 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 16 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
Lymphoma, Non-Hodgkin
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Required: * PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine. * Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches. * Antiretroviral agent available by therapy IND. * MAI prophylaxis with rifabutin (in patients with CD4 counts \< 100 cells/mm3). Patients must have: * HIV infection. * Primary CNS lymphoma with NO systemic involvement. Prior Medication: Allowed: * Prior corticosteroids. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin. * Active uncontrolled infection. * Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration. * Active heart disease (congestive heart failure or heart block greater than first degree on EKG). Concurrent Medication: Excluded: * Any investigational agent other than antiretroviral agents available by therapy IND. Patients with the following prior conditions are excluded: * No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin. * No new infectious complications within the past 2 weeks that require a change in antibiotics. * History of myocardial infarction within the past 3 months. Prior Medication: Excluded: * Prior chemotherapy other than for Kaposi's sarcoma.



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 7 ubicaciones
Suspendido
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United StatesVer ubicación
Suspendido
San Francisco Gen HospSan Francisco, United States
Suspendido
Univ of Colorado Health Sciences CtrDenver, United States
Suspendido
Beth Israel Deaconess - West CampusBoston, United States

Completado7 Centros de Estudio