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- Ensayo clínico NCT00074243
CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas
RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas.
- Determine, preliminarily, the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
Secondary
- Determine, preliminarily, the potential anti-glioma activity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral CC-8490 once daily on days 1 and 3-28 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive oral CC-8490 once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-8490 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 10 patients are treated at that dose.
Patients are followed within 2 weeks.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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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 confirmed supratentorial malignant glioma, including any of the following:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant glioma/astrocytoma not otherwise specified OR
- Clinical and radiographic diagnosis of progressive low-grade glioma
- Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed
Recurrent or progressive disease as determined by 1 of the following:
- CT scan or MRI within the past 21 days
- Biopsy within the past 12 weeks
- Failed prior radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- More than 8 weeks
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3 (transfusion independent)
- Hemoglobin at least 8 g/dL (transfusion allowed)
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 2 times upper limit of normal
- No significant active hepatic disease that would preclude study participation
Renal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- No significant active renal disease that would preclude study participation
Cardiovascular
- No significant active cardiac disease that would preclude study participation
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No significant active psychiatric disease that would preclude study participation
- No other condition or laboratory abnormality that would preclude study participation
- Able to swallow capsules whole
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 2 weeks since prior interferon
- No concurrent immunotherapy
Chemotherapy
- At least 2 weeks since prior vincristine
- At least 3 weeks since prior procarbazine
- At least 4 weeks since prior temozolomide or carboplatin
- At least 6 weeks since prior nitrosoureas
- No other concurrent anticancer chemotherapy
Endocrine therapy
- At least 2 weeks since prior tamoxifen
- Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment
Radiotherapy
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- At least 2 weeks since prior resection of a recurrent or progressive tumor
Other
- At least 2 weeks since other prior non-cytotoxic therapy
- At least 4 weeks since other prior cytotoxic therapies
- More than 28 days since prior experimental study drugs
- No other concurrent investigational agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Howard A. Fine, MD, NCI - Neuro-Oncology Branch
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- Enfermedades del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Glioma
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
Otros números de identificación del estudio
- CDR0000343702
- NCI-04-C-0035
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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