Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.
Alitretinoin
Infecciones Transmitidas por la Sangre+18
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active. Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 27 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
Inclusion Criteria Patients must have: HIV positive status and histologic confirmation of KS. CD4 count > 200 mm3 (required of one-half of patients). Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions. Acceptable organ system function. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. Prior Medication: Excluded: Systemic therapy for KS within 30 days. Local or topical therapy for KS indicative lesions within 60 days. Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug. Required: Approved antiretroviral therapy.