A Trial of 06-BG and BCNU in Children With CNS Tumors
O6-benzylguanine
+ carmustine
Enfermedades del Cerebro+18
+ Neoplasias Cerebrales
+ Enfermedades del Sistema Nervioso Central
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicity of carmustine administered after O6-benzylguanine in children with refractory primary CNS tumors. II. Determine a safe and tolerable dose of carmustine administered after O6-benzylguanine to be used in phase II studies. III. Determine the pharmacokinetics of O6-benzylguanine and its metabolite, O6-benzyl-8-oxoguanine, in these patients. IV. Seek preliminary evidence of antitumor activity of this regimen in these patients. V. Evaluate the acute and chronic toxicities, and describe cumulative toxicity, in patients treated with multiple courses of this regimen. OUTLINE: This is a dose escalation study of carmustine. Patients receive O6-benzylguanine IV over 1 hour, then, 1 hour later, carmustine IV is administered over 1 hour. Treatment is repeated every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of carmustine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose level at which fewer than 2 of 6 patients experience dose limiting toxicity (DLT). If myelosuppression is the DLT, stratum 1 is closed and patients are accrued to stratum 2. If neutropenia is the DLT in stratum 2, patients receive filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until blood counts recover. Patients are followed every 6 months for 4 years, then annually thereafter.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 36 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 or cytologically proven CNS tumor that is refractory to conventional therapy or for which no effective therapy is known Histological requirement may be waived for brainstem and optic gliomas Stratum 2: No bone marrow involvement PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Karnofsky 50-100% OR Lansky 50-100% Life expectancy: At least 8 weeks Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 (stratum 2: at least 125,000/mm3) Hemoglobin at least 8 g/dL Bilirubin less than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times normal Creatinine or GFR normal for age If required, DLCO must be 80% of normal and patient old enough to cooperate for DLCO test Neurologic deficits must be stable for at least 2 weeks prior to study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: At least 7 days since prior biologic therapy or immunotherapy and recovered At least 6 months since prior bone marrow transplant (stratum 1 only) At least 7 days since prior growth factors No concurrent filgrastim (G-CSF) prophylaxis Stratum 2: No prior bone marrow transplantation At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered Stratum 2: No greater than 2 prior chemotherapy regimens No prior nitrosourea therapy If receiving dexamethasone, must be on stable or decreasing dose for at least 2 weeks prior to study At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 months since prior substantial bone marrow radiation, total body irradiation, hemipelvic radiotherapy, or total abdominal/pelvic/chest or mantle/Y ports radiotherapy Recovered from prior radiotherapy Stratum 2: No prior central axis radiation No other concurrent anticancer or investigational agents
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 56 ubicaciones
University of Arkansas for Medical Sciences
Little Rock, United StatesAbrir University of Arkansas for Medical Sciences en Google MapsUniversity of California San Diego Cancer Center
La Jolla, United StatesChildren's Hospital Los Angeles
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United States