A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors.
filgrastim
+ carboplatin
+ cyclophosphamide
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors. Determine the toxicity of this regimen in these patients. OUTLINE: This is a dose escalation study of thiotepa. Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim (G-CSF) support and peripheral blood stem cell (PBSC) collection. Patients receive thiotepa IV over 2 hours on days 0 and 1; topotecan IV over 30 minutes on days 0-4; and carboplatin IV over 2 hours on days 2 and 3. Patients also receive G-CSF beginning on day 5, 24-36 hours following the last dose of topotecan. PBSC are reinfused on day 6 (36-48 hours following the last dose of topotecan) of each course of therapy. Patients receive 3 courses of therapy. Cohorts of 3-6 patients receive escalating doses of thiotepa 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 at 1 and 2 years. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued into this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 24 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 1 a 30 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.Criterios
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory pediatric solid tumor Bone marrow metastases allowed PATIENT CHARACTERISTICS: Age: 1 to 30 Performance status: 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 2.5 times normal Renal: Adequate renal function as defined by one of the following: GFR by creatinine clearance Radioisotope GFR Iothalamate at least 70 mL/min Cardiovascular: Adequate cardiac function as defined by one of the following: Ejection fraction at least 55% by MUGA Fractional shortening at least 28% by echocardiogram Neurologic: Adequate CNS function as defined by: Seizure disorder, if present, controlled by anticonvulsants CNS toxicity no greater than grade 2 Other: No uncontrolled infections Not pregnant or nursing No allergy to platinum compounds No history of allergy to etoposide (unless mobilization phase not required) PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior immunotherapy At least 1 week since prior cytokines At least 3 months since prior bone marrow or peripheral blood stem cell transplantation No concurrent immunomodulator No concurrent cytokines Chemotherapy: At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered No prior thiotepa No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy At least 6 months since prior total body irradiation conditioning No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow Surgery: Not specified
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 2 ubicaciones
Children's Hospital and Regional Medical Center - Seattle
Seattle, United StatesAbrir Children's Hospital and Regional Medical Center - Seattle en Google MapsFred Hutchinson Cancer Research Center
Seattle, United States