- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00014521
Karenitecin in Treating Patients With Recurrent Malignant Glioma
Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas
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 karenitecin in treating patients who have recurrent malignant glioma.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex.
- Determine the pharmacokinetics of this drug in these patients.
- Assess the preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs no).
Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33%.
Patients are followed every 2 months.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study within 1 year.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Florida
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Tampa, Florida, Estados Unidos, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Winship Cancer Institute of Emory University
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231
- Sidney kimmel comprehensive cancer center at johns hopkins
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157-1030
- Comprehensive Cancer Center at Wake Forest University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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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 anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme
Progressive or recurrent disease previously treated with radiotherapy with or without chemotherapy
- Prior low-grade disease that progressed to high-grade after therapy allowed
- Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 8.5 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- Transaminases no greater than 4 times upper limit of normal
Renal:
- Creatinine no greater than 1.7 mg/dL
Other:
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
- No serious concurrent infection
- No other medical illness that would preclude study
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No more than 1 prior chemotherapy regimen
Endocrine therapy:
- Must be on stable dose of steroids for at least 5 days
Radiotherapy:
- See Disease Characteristics
- At least 3 months since prior radiotherapy and recovered
- No more than 1 prior course of radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational agents
- At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
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
- CDR0000068552
- NABTT-2006
- JHOC-NABTT-2006
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