Etopósido Oral de Baja Dosis para el Tratamiento del Sarcoma de Kaposi Relacionado con el SIDA en Casos de Recaída o Progresión
Este estudio tiene como objetivo evaluar la efectividad de la administración oral de bajas dosis de Etopósido como tratamiento para individuos con sarcoma de Kaposi relacionado con el SIDA que ha experimentado una recaída o una progresión.
Etoposide
Infecciones Transmitidas por la Sangre+19
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time. Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle. Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles. If there are no responses to therapy among the first 14 evaluable patients, the study will close; if there is at least one objective response to therapy among the first 14 evaluable patients, enrollment will continue until all 41 patients are enrolled. Patients continue therapy until maximal tumor response (either stable disease or complete response) is achieved or disease progression occurs.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 41 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 12 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
Inclusion Criteria Concurrent Medication: Allowed: Maintenance therapy for opportunistic infections. Patients must have: HIV infection. Kaposi's sarcoma that has relapsed or progressed. Mucocutaneous lesions (15 or more) and/or symptomatic mucosal lesions and/or visceral Kaposi's sarcoma (symptomatic lymphedema qualifies patients in the absence of these three conditions). NO active acute opportunistic infections requiring treatment with myelosuppressive antibiotics (maintenance for OIs is permitted). Consent of parent or guardian if less than 18 years of age. NOTE: This study is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Other active malignancies except basal cell carcinoma of the skin, or carcinoma in situ of the cervix. Grade 3 or worse peripheral neuropathy. Altered mental status that would prevent informed consent or prevent study compliance. Patients with the following prior condition are excluded: Neuropsychiatric history. Prior Medication: Excluded: Prior etoposide. Any other anti-KS drugs within 14 days prior to study entry. Any investigational drug other than antiretrovirals within 14 days prior to study entry. Any prior investigational agent, if given as the ONLY prior treatment for KS. Prior Treatment: Excluded: Radiation therapy within 7 days prior to study entry. Continued alcohol consumption or continued intravenous drug use that would impair ability to comply with study requirements.
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 20 ubicaciones
Univ of Alabama at Birmingham
Birmingham, United StatesAbrir Univ of Alabama at Birmingham en Google MapsK Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, United StatesUniv of Southern California / LA County USC Med Ctr
Los Angeles, United StatesSan Francisco Gen Hosp
San Francisco, United States