- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00900445
Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)
Descripción general del estudio
Estado
Descripción detallada
PRIMARY OBJECTIVES:
I. To compare the pharmacokinetics of prednisone/prednisolone, vincristine, and daunorubicin hydrochloride among obese, middle-weight, and underweight children aged 10 to less than 20 years of age undergoing induction therapy for high-risk acute lymphoblastic leukemia.
II. To examine the relationship between the above parameters and response status as defined by early response and induction failure
OUTLINE: This is a multicenter study. Patients are stratified according to body mass index (BMI) (greater than or equal to 95th percentile [obese] vs 10th to 95th percentile [normal or at risk for overweight] vs less than or equal to 10th percentile [underweight]).
Patients receive anticancer therapy as prescribed by their treating clinicians. Patients receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.
Blood samples are obtained on either day 1 or day 8** of induction therapy for pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine activity levels.
Blood samples are analyzed via high-performance liquid chromatography (HPLC), ultrafiltration, a Nessler reaction, ELISA, and liquid chromatography using reverse-phase chromatography, fluorescent detection, and solid-phase extraction.
Demographic information, including ethnicity, is also collected. Weight and height is recorded at diagnosis and on the day pharmacokinetic assessment of vincristine, prednisone, and daunorubicin hydrochloride begins.
NOTE: **Patients who are being sampled on day 8 of induction therapy and who have received intravenous corticosteroid therapy in the first week of induction must have received at least six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on day 8.
Tipo de estudio
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Childrens Oncology Group
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Descripción
Inclusion Criteria:
- Patients must be newly diagnosed with acute lymphoblastic leukemia and the intended induction treatment must contain prednisone/prednisolone, vincristine and daunorubicin in the doses and schedule as per the current COG AALL0232 protocol; prior registration onto a COG protocol is not required
- Patients must be able to take either prednisone/prednisolone reliably by mouth on day 1 or 8 of induction (depending on sampling schedule chosen); patients who are being sampled on Induction day 8 and who have received intravenous corticosteroid therapy in the first week of induction must have received a minimum of six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on induction day 8
Exclusion Criteria:
- Serum transaminase concentrations >= 5 X ULN for age
- Total serum bilirubin (conjugated + unconjugated) >= 1.5 mg/dl (>= 26 micromol/L)
- Serum creatinine > 1.5 X ULN for age
- With the exception of prednisone/prednisolone, receipt of medications or food known or with the potential to alter the pharmacokinetics of the drugs under study within 14 days of diagnosis and throughout the period of pharmacokinetic sampling; such agents include but are not limited to: grapefruit, tangelos or the juice of these fruits; St. Johns wort; anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, phenobarbital, primidone; azole antifungal agents: ketoconazole, fluconazole, itraconazole, voriconazole; macrolide antibiotics: erythromycin, clarithromycin; isoniazid; rifampin; verapamil; and diltiazem
- Presence of known malabsorption syndrome
- Females with known pregnancy (pregnancy test must be negative to be eligible)
Plan de estudios
¿Cómo está diseñado el estudio?
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Basic science (pharmacokinetics)
Patients receive anticancer therapy as prescribed by their treating clinicians.
Patients receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.
|
Estudios correlativos
Dado IV
Otros nombres:
Dado IV
Otros nombres:
Administrado oralmente
Otros nombres:
Given orally
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pharmacokinetic parameters of prednisone/prednisolone
Periodo de tiempo: Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours
|
Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
|
Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours
|
Pharmacokinetic parameters of daunorubicin hydrochloride
Periodo de tiempo: Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours
|
Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
|
Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours
|
Pharmacokinetic parameters of vincristine sulfate
Periodo de tiempo: Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours
|
Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
|
Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
RER and SER status
Periodo de tiempo: Up to 1.5 years
|
To examine the relationship between pharmacokinetic parameters and RER versus SER status, univariate and multiple logistic regressions will be performed.
|
Up to 1.5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ian Pollack, Children's Oncology Group
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Leucemia
- Leucemia-linfoma linfoblástico de células precursoras
- Leucemia Linfoide
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Agentes antiinflamatorios
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Antieméticos
- Agentes Gastrointestinales
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Agentes neuroprotectores
- Agentes Protectores
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Prednisolona
- Acetato de metilprednisolona
- Metilprednisolona
- Hemisuccinato de metilprednisolona
- Acetato de prednisolona
- Hemisuccinato de prednisolona
- Fosfato de prednisolona
- Prednisona
- Vincristina
- Daunorrubicina
- Hidrocortisona
- Hidrocortisona 17-butirato 21-propionato
- Acetato de hidrocortisona
- Hemisuccinato de hidrocortisona
- Cortisona
Otros números de identificación del estudio
- ACCL0631 (Otro identificador: CTEP)
- U10CA095861 (Subvención/contrato del NIH de EE. UU.)
- NCI-2011-02151 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- CDR0000588173
- COG-ACCL0631 (Otro identificador: DCP)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Estudio farmacológico
-
University of MichiganTerminado
-
University of MichiganTerminado
-
Digisight Technologies, Inc.DesconocidoRetinopatía diabética | La degeneración macular relacionada con la edad | MetamorfopsiaEstados Unidos
-
Radicle ScienceTerminadoEstrés | AnsiedadEstados Unidos
-
Radicle ScienceTerminadoDepresión | Dolor | Dormir | AnsiedadEstados Unidos
-
Seno Medical Instruments Inc.Terminado
-
University of MichiganActivo, no reclutandoDepresión | Actividad física | Dormir | Estado animicoEstados Unidos
-
University of MichiganTerminadoDepresión | Actividad física | Dormir | Estado animicoEstados Unidos
-
Cairo UniversityAún no reclutandoCefalea cervicogénica
-
Hospital Clinic of BarcelonaUniversitat Politècnica de Catalunya; Institut Catala de Salut; Department of Health... y otros colaboradoresDesconocidoAtención Integrada | Telesalud | Racionamiento de la atención médicaEspaña