A Phase I Dose Escalation Study of Intrathecal DepoFoam Encapsulated Cytarabine (DTC 101) in Pediatric Patients With Advanced Meningeal Malignancies
liposomal cytarabine
Infecciones por virus ADN+24
+ Enfermedades Hematológicas
+ Enfermedades hemáticas y linfáticas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the qualitative or quantitative toxic effects and tolerability of liposomal cytarabine (Depofoam encapsulated cytarabine; DTC 101) in pediatric patients with recurrent or refractory meningeal malignancies. II. Define a safe dose of DTC 101 in these patients for future clinical studies. III. Determine the plasma and CSF pharmacokinetics of DTC 101 in these patients. OUTLINE: This is a dose escalation, multicenter study. Patients are placed in one of three age-related strata: stratum 1, 3 to 21 years of age; stratum 2, at least 2 but less than 3 years of age; stratum 3, at least 1 but less than 2 years of age. Patients receive an induction dose of intrathecal liposomal cytarabine (Depofoam encapsulated cytarabine; DTC 101) administered once every 2 weeks for 2 courses. Patients who have achieved a partial response or received significant clinical benefit with stable disease may receive a third induction dose of DTC 101, 2 weeks following the second dose. In the absence of progressive disease, patients can proceed to consolidation therapy. During consolidation therapy, intrathecal DTC 101 is administered once every 4 weeks for 2 courses, beginning 4 weeks after the last induction dose. Patients experiencing a complete or significant response can proceed to maintenance therapy. Patients receive a maintenance dose of intrathecal DTC 101 once every 8 weeks for a total of 6 doses, beginning 4 weeks after the second consolidation dose. At least 3 patients are evaluated at each dose level. Dose escalation to the next level proceeds when a minimum of 3 patients per cohort has successfully completed induction therapy and been evaluated. Patients will be followed at 1, 2, 3, 6, 9, and 12 months post treatment, until relapse or death. PROJECTED ACCRUAL: A minimum of 12-15 patients will be accrued for each stratum over 18 to 24 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 15 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 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 recurrent or refractory leukemia, lymphoma, or other solid tumor that has overt meningeal involvement Definition of meningeal disease: Leukemia/lymphoma: CSF cell count at least 5/mm3 and evidence of blast cells on cytospin preparation or cytology Solid tumors: Presence of tumor cells on cytospin preparation or cytology OR evidence of meningeal disease on CT or MRI scan No bone marrow disease PATIENT CHARACTERISTICS: Age: 1 to 21 Performance Status: ECOG 0-2 Life Expectancy: At least 8 weeks Hematopoietic: Platelet count greater than 40,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL ALT less than 5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Effective contraceptive method used by fertile patients No uncontrolled illness or infection (except for HIV positive patients) No obstructive hydrocephalus or compartmentalization of the CSF flow PRIOR CONCURRENT THERAPY: Biologic therapy: No acute toxic effects from prior immunotherapy No prior allogeneic or autologous bone marrow transplantations within 3 months of study Chemotherapy: No prior systemic CNS directed chemotherapy within 3 weeks of study No prior nitrosourea within 6 weeks of study No prior intrathecal chemotherapy within 1 week of study No acute toxic effects from prior chemotherapy No prior DTC 101 Concurrent systemic chemotherapy for management of primary cancer allowed Concurrent dexamethasone with systemic chemotherapy regimen allowed No concurrent chemotherapy for leptomeningeal disease No concurrent high dose methotrexate, high dose cytarabine, mercaptopurine, thiotepa, fluorouracil, and topotecan Endocrine therapy: Concurrent prednisone therapy with systemic chemotherapy allowed Radiotherapy: No prior craniospinal irradiation within 8 weeks of study No acute toxic effects from prior radiotherapy Concurrent local radiation therapy allowed No concurrent whole brain or craniospinal radiotherapy Surgery: Not specified Other: At least 2 weeks since investigational drugs and recovered No other concurrent investigational drugs Concurrent antibiotic therapy allowed
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 6 ubicaciones
Children's Hospital Los Angeles
Los Angeles, United StatesAbrir Children's Hospital Los Angeles en Google MapsStanford University Medical Center
Stanford, United StatesUniversity of Texas Southwestern Medical Center at Dallas
Dallas, United StatesTexas Children's Cancer Center
Houston, United States