Phase I Study of Arsenic Trioxide
arsenic trioxide
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de agosto de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of arsenic trioxide in adult and pediatric patients with advanced solid tumors. II. Determine the pattern of clinical adverse experience of arsenic trioxide in this patient population. III. Evaluate evidence of clinical responsiveness to this treatment regimen. OUTLINE: This is a dose escalation, open label study. Patients are stratified by age (pediatric vs adult). Patients receive arsenic trioxide IV over 1-2 hours once daily for 3 consecutive days then once weekly for 5 weeks. Patients with stable or responding disease receive additional courses of therapy every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity. Patients are followed for at least 1 month after treatment. PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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.Criterios
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor Relapsed from or resistant to at least 1 course of standard anticancer therapy AND/OR Lack of standard therapy that is known to be beneficial in the underlying disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 4 months following study No active serious infections that are not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents
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
Memorial Sloan-Kettering Cancer Center
New York, United StatesAbrir Memorial Sloan-Kettering Cancer Center en Google Maps