- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00024284
Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors.
- Determine the safety profile and dose-limiting toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the preliminary anti-tumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of carboplatin and irinotecan.
Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9 months.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital For Sick Children
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Arizona
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Tucson, Arizona, Estados Unidos, 85724
- Arizona Cancer Center
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-2916
- Children's National Medical Center
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63105
- Washington University Medical Center
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105-2794
- St. Jude Children's Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor, including primary brain tumor
- Progressive disease on standard therapy or for which no standard therapy exists
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
- 1 to 21
Performance status:
- Lansky 50-100% (age 10 and under)
- Karnofsky 50-100% (over age 10)
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- ALT no greater than 2.5 times upper limit of normal
Renal:
- Glomerular filtration rate at least 30 mL/min
Other:
- No active infection
- No serious uncontrolled medical disorder
- No psychiatric disorder or other disorder that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease
- At least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunotherapy
Chemotherapy:
- No more than 3 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- Concurrent hormone replacement therapy or oral contraceptives allowed
- No other concurrent hormonal therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy (including for brain metastases) and recovered
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational anticancer drugs
- No other concurrent antitumor therapy
- No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Ashwin Gollerkeri, MD, Bristol-Myers Squibb
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000068908
- BMS-CA124-001
- CNMC-2782
- MSKCC-01071
- SJCRH-CARCPT
- NCI-G01-2016
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. .
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