SU101 como inhibidor del receptor de PDGF para malignidades pediátricas refractarias
Este estudio tiene como objetivo evaluar la seguridad y eficacia de SU101 como inhibidor del receptor de PDGF en el tratamiento de malignidades refractarias en niños.
SU101
Neoplasias+4
+ Neoplasias por tipo histológico
+ Neoplasias de Células Germinales y Embrionarias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1997
Fecha en la que se inscribió al primer participante.SU101 is a member of a novel class of antineoplastic agents, platelet-derived growth factor (PDGF) receptor inhibitors. Preclinical data suggests that SU101 might be an effective agent against neuroglial tumors as well as a variety of sarcomas. A pediatric phase I trial of SU101 in children with these malignancies will be conducted to find the maximum tolerated dose of SU101 and define the toxicity profile of this agent. In addition, we will define the pharmacokinetics of SU101 and its active metabolite SU0020 in pediatric patients and gather preliminary information regarding response.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 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.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically proven primary CNS malignancy, neuroblastoma or sarcoma that is refractory to standard therapy or for which no standard therapy exists and disease can not be cured by surgery. PRIOR/CONCURRENT THERAPY: Recovered from toxic affects of all prior therapy. No investigational agent within past 2 weeks. BIOLOGY THERAPY: Not specified. CHEMOTHERAPY: No myelosuppressive therapy within past 3 weeks. No nitrosourea within past 6 weeks. ENDOCRINE THERAPY: If receiving dexamethasone dose must be stable for at least 2 weeks. RADIOTHERAPY: Not specified. SURGERY: Not specified. PATIENT CHARACTERISTICS: Age: 3 to 21. Performance status: ECOG 0-2. Life expectancy: At least 8 weeks. HEMATOPOIETIC: AGC greater than 1500/mm(3). Hemoglobin greater than or equal to 8.0 g/dL percent. Platelet count greater than 100,000/mm(3). For patients with bone marrow involvement or history of bone marrow transplantation or craniospinal radiotherapy: AGC greater than 750/mm(3), Hemoglobin greater than 6.0 g/dL, Platelet count greater than 50,000/mm(3). HEPATIC: SGOT, SGPT or alkaline phosphatase less than 3 times upper limit of normal. Bilirubin no less than or equal to 1.5 times upper limit of normal. RENAL: Ages 3-5 Creatinine no greater than 0.8 mg/dL. Ages 5-10 Creatinine no greater than 1.0 mg/dL. Ages 10-15 Creatinine no greater than 1.2 mg/dL. Ages 16-21 Creatinine no greater than 1.5 mg/dL. OTHER: All patients or their legal guardians (if the patient is under 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study. For patients with brain tumors who are over 18 years of age, a DPA should be signed. Not pregnant or nursing. Not allergic to etoposide. No acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results.
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
National Cancer Institute (NCI)
Bethesda, United StatesAbrir National Cancer Institute (NCI) en Google Maps