Dosis de Fenretinida y sus Efectos en Niños con Tumores Sólidos de Alto Riesgo
Este estudio tiene como objetivo determinar la dosis segura y observar los efectos de la Fenretinida en niños diagnosticados con tumores sólidos de alto riesgo.
Ensayo Clínico del Medicamento Fenretinide
Neoplasias+3
+ Neoplasias por tipo histológico
+ Neoplasias de Células Germinales y Embrionarias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the maximum tolerated dose of fenretinide (HPR) in children with high risk solid tumors. II. Determine the toxicities of HPR in these patients. III. Determine the pharmacokinetics of HPR in these patients. IV. Determine the CSF level of HPR in patients whom cerebrospinal fluid is obtained for routine purposes while on this study. V. Determine the effect of HPR on plasma retinol levels in these patients. VI. Determine the activity of HPR in these patients. VII. Determine the antitumor activity of HPR on minimal residual bone marrow disease in neuroblastoma. OUTLINE: This is a dose escalation study. Patients receive oral fenretinide 3 times a day on days 1-7. Treatment repeats every 3 weeks for up to 8 courses. Patients may receive an additional 22 courses of therapy in the presence of stable or responding residual tumor. Patients with recurrent neuroblastoma, after prior myeloablative therapy with no measurable disease, will stop treatment after 8 courses. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed until death.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 18 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.Hasta 21 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
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor that is refractory to conventional therapy or recurrent neuroblastoma treated with myeloablative therapy and autologous stem cell transplant in second complete or partial response Bone marrow metastases with granulocytopenia, anemia, and/or thrombocytopenia are eligible PATIENT CHARACTERISTICS: Age: Under 21 at diagnosis Performance status: CCG 0-2 Life expectancy: At least 2 months Absolute neutrophil count at least 750/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 7.0 g/dL Bilirubin no greater than 1.5 mg/dL SGOT and SGPT less than 2.5 times normal Creatinine no greater than 1.5 g/dL OR creatinine clearance at least 50 mL/min OR radioisotope GFR at least 50 mL/min Seizure disorders controlled with anticonvulsants allowed No CNS toxicity greater than grade 2 Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: At least 1 month since prior autologous stem cell transplantation No prior allogeneic transplantation At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered No other concurrent chemotherapy No concurrent immunomodulating agents (including steroids) Concurrent corticosteroid therapy for increased intracranial pressure allowed Concurrent dexamethasone for CNS tumor allowed At least 2 weeks since prior radiotherapy Concurrent radiotherapy to localized lesions allowed At least 2 weeks since prior retinoids Prior isotretinoin or 9-cis-retinoic acid allowed
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalCentros 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 26 ubicaciones
Cancer Center and Beckman Research Institute, City of Hope
Duarte, United StatesAbrir Cancer Center and Beckman Research Institute, City of Hope en Google MapsLong Beach Memorial Medical Center
Long Beach, United StatesChildren's Hospital Los Angeles
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United States