Quimioterapia de Consolidación de Alta Dosis con Soporte de Células Madre Hematopoyéticas Periféricas para Tumores Embrionarios del Sistema Nervioso Central de Alto Riesgo
Este estudio de fase 2 tiene como objetivo evaluar la efectividad de la quimioterapia de consolidación de alta dosis con soporte de células madre progenitoras hematopoyéticas periféricas (PBSC) para mejorar la supervivencia libre de eventos en individuos diagnosticados con tumores embrionarios del sistema nervioso central de alto riesgo.
filgrastim
+ carboplatin
+ cyclophosphamide
Neoplasias+6
+ Neoplasias por tipo histológico
+ Neoplasias por Sitio
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the safety of postradiotherapy high-dose consolidation chemotherapy with peripheral blood stem cell (PBSC) support in patients with high-risk primitive neuroectodermal tumors. Determine the safety of delaying radiotherapy by approximately one month in these patients. Determine the maximum tolerated dose of thiotepa in these patients. Determine the toxic effects of intensive chemotherapy with PBSC support in these patients. Assess the time to hematopoietic recovery after PBSC infusion when intensive chemotherapy is used after craniospinal radiotherapy in these patients. Determine the overall and event-free survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study of thiotepa during consolidation therapy. Induction: Within 31 days of initial surgery, patients receive induction therapy comprising vincristine IV on day 0, cyclophosphamide IV over 2 hours on days 0 and 1, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 2 and continuing for at least 7-10 days. Peripheral blood stem cells (PBSC) are then collected. Chemoradiotherapy: After blood cell counts recover, and within 28 days of starting induction, patients begin chemoradiotherapy. Patients receive vincristine IV once weekly for 8 doses. Radiotherapy is administered 5 days a week, for 6 weeks, beginning within the same week as the start of vincristine. Consolidation: Therapy begins 4-6 weeks after the last radiation treatment in the absence of disease progression. The first and third course are the same and comprise vincristine IV on day 0, carboplatin IV over 1 hour on days 0 and 1, thiotepa IV over 3 hours on days 2-4, and G-CSF SC daily beginning on day 7. PBSC are reinfused on day 7. The second course comprises vincristine IV on day 0, carboplatin IV over 1 hour on days 0 and 1, cyclophosphamide IV over 2 hours on days 2 and 3, and G-CSF SC daily beginning on day 5. PBSC are reinfused on day 5. Each course lasts 21 days. For consolidation therapy, cohorts of 6-12 patients each receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 12 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 24-56 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.Se reclutarán 25 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.De 3 a 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 proven primitive neuroectodermal tumor (PNET) of one of the following types: Atypical teratoid/rhabdoid tumor Medulloblastoma Desmoplastic medulloblastoma Ependymoblastoma Medullomyoblastoma Spongioblastoma Spongioblastoma polare Primitive polar spongioblastoma Medulloepithelioma Neuroblastoma Pineoblastoma Posterior fossa PNET must be M1-3 or M0 with greater than 1.5 cm2 residual disease Non posterior fossa PNET and other types must be M0-3 If M3, must show clear evidence of tumor on MRI No marrow involvement or other extraneural metastases No M4 disease No cord compression requiring emergency radiotherapy PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 150,000/mm^3 (no platelet transfusions) Hemoglobin at least 10 g/dL (red blood cell transfusions allowed) Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST or ALT less than 2.5 times ULN Renal: Creatinine clearance or glomerular filtration rate at least 70 mL/min Cardiovascular: Shortening fraction greater than 27% by echocardiogram OR Ejection fraction greater than 47% by MUGA Pulmonary: FEV_1/FVC greater than 60% except for children who: Are uncooperative Have no dyspnea at rest Have no exercise intolerance Have pulse oximetry greater than 94% on room air Other: Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Steroids for increased intracranial pressure allowed Radiotherapy: See Disease Characteristics No prior urgent radiotherapy Surgery: Not specified Other: No prior therapy for tumor
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
ExperimentalObjetivos del Estudio
Objetivos Primarios
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 13 ubicaciones
Children's Hospital Los Angeles
Los Angeles, United StatesAbrir Children's Hospital Los Angeles en Google MapsJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesChildren's Hospital of Orange County
Orange, United StatesChildren's Hospital of Denver
Denver, United States