- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00389090
A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This open-label, multicenter, phase II trial will assess the antitumor activity and safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic glioma.
Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be enrolled in this study. Total accrual on this study will not exceed 116 patients. The patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning immediately after the first bolus infusion and continuing until immediately prior to the last bolus injection. Patients will be evaluated for AEs during the course of therapy. Patients may receive treatment at the same dose level until appearance of significant treatment-related toxicities, disease progression or withdrawal of consent.
Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles for the duration of therapy, using physical and neurological examinations and diagnostic imaging.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90033
- AOI Pharmaceuticals Investigative Site
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Florida
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Orlando, Florida, Estados Unidos, 32804
- AOI Pharmaceuticals Investigative Site
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- AOI Pharmaceuticals Investigative Site
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Evanston, Illinois, Estados Unidos, 60201
- AOI Pharmaceuticals Investigative Site
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- AOI Pharmaceuticals Investigative Site
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Louisville, Kentucky, Estados Unidos, 40202
- AOI Pharmaceuticals Investigative Site
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 54407
- AOI Pharmaceuticals Investigative Site
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- AOI Pharmaceuticals Investigative Site
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
- AOI Pharmaceuticals Investigative Site
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Texas
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Dallas, Texas, Estados Unidos, 75246
- AOI Pharmaceuticals Investigative Site
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Houston, Texas, Estados Unidos, 77024
- AOI Pharmaceuticals Investigative Site
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- AOI Pharmaceuticals Investigative Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with histologically documented anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).
- Temozolomide-resistant defined as patients who have progressed while receiving or within 8 weeks of completing the last dose of temozolomide.
- Disease progression >= 12 weeks after the completion of any radiotherapy.
- If patient received chemotherapy or an investigational agent as part of their prior therapy, the patient must recover from all toxicities (<= Grade 1) prior to enrollment on this protocol.
- Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging study (MRI) performed within two weeks of study drug administration.
- If patient received intratumoral chemotherapy or immunotherapy as part of their prior therapy then histological confirmation of recurrence is mandated.
- KPS >= 70%.
The following laboratory results:
- Absolute neutrophil count >= 1500 cells/microliter
- Platelet count >= 100,000 cells/microliter
- SGOT <= 2.5 x ULN
- Serum creatinine <= 1.5 x ULN
- Signed informed consent approved by Institutional Review Board.
- If sexually active, patients will take contraceptive measures for the duration of the treatment.
- For patients on corticosteroids, they must have been on a stable dose 1 week prior to baseline MRI and the dose should not be escalated over entry dose level, if clinically possible.
Exclusion Criteria:
- Pregnant or breast feeding women.
- Prior treatment with O6-BG plus temozolomide in combination.
- Active infection requiring intravenous antibiotics.
- Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not mandatory).
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Patients unwilling or unable to comply with the protocol.
- Patients who have received stereotactic radiosurgery or brachytherapy as part of their prior therapy.
- Comedication that may interfere with study results; eg. immunosuppressive agents other than corticosteroids.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Temozolomide + O6BG
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O6BG + Temozolomide
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
best objective response rate
Periodo de tiempo: Month 1, 2 and every 2 months thereafter.
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Month 1, 2 and every 2 months thereafter.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Safety Assessment
Periodo de tiempo: Month 1, 2 and every 2 months thereafter
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Month 1, 2 and every 2 months thereafter
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progression-free survival
Periodo de tiempo: every 6 months
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every 6 months
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overall survival
Periodo de tiempo: every 6 months
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every 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Jennifer Quinn, MD, Preston Robert Tisch Brain Tumor Center at Duke
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
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Glandulares y Epiteliales
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Glioma
- Astrocitoma
- Oligodendroglioma
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Temozolomida
- O(6)-bencilguanina
Otros números de identificación del estudio
- O6BG 202
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