Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
temozolomide
Enfermedades del Cerebro+17
+ Enfermedades del Sistema Nervioso Central
+ Enfermedades del Nervio Craneal
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide. Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients. OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma). Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 100 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 4 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including: Astrocytoma Oligodendroglioma Mixed glioma Optic pathway glioma* Pontine glioma* NOTE: *Biopsy not required Patients with optic pathway glioma must also meet the following criteria: Progressive loss of vision as defined by doubling of octaves Visual acuity loss not explained by other causes Increase in proptosis of greater than 3 mm Increase in diameter of optic nerve of at least 2 mm on neuroimaging Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI PATIENT CHARACTERISTICS: Age: 4 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 1.5 times ULN BUN less than 1.5 times ULN Other: Must be neurologically stable No systemic disease No acute infection requiring IV antibiotics No frequent vomiting No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction) No other prior or concurrent malignancies except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy (growth factors or epoetin alfa) Chemotherapy: At least 6 weeks since prior chemotherapy unless evidence of disease progression No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since prior radiotherapy unless evidence of disease progression No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery unless evidence of disease progression Recovered from all prior surgery Other: No other concurrent investigational drugs
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Duke Comprehensive Cancer Center
Durham, United StatesAbrir Duke Comprehensive Cancer Center en Google MapsChildren's Hospital of Philadelphia
Philadelphia, United States