Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Patients With Glioblastoma Multiforme
acridine carboxamide
Astrocitoma+11
+ Enfermedades del Cerebro
+ Enfermedades del Sistema Nervioso Central
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the efficacy acridine carboxzmide in terms of objective response rate and response duration in patients with glioblastoma multiforme. II. Determine the toxicities of this treatment regimen in this patient population. OUTLINE: This is a multicenter study. Patients receive acridine carboxamide IV continuously over days 1-5. Treatment repeats every 3 weeks for at least 2 courses and up to a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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 18 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 or cytologically confirmed recurrent glioblastoma multiforme Measurable disease on contrast MRI Lesion at least 2 cm in diameter PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Transaminases no greater than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Normal cardiac function No ischemic heart disease within the past 6 months Normal electrocardiogram Other: No unstable systemic diseases No active uncontrolled infections No prior or other concurrent malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior adjuvant chemotherapy for brain tumor No other prior chemotherapy Endocrine therapy: Must be on stable or decreasing doses of corticosteroids for at least 2 weeks Radiotherapy: At least 3 months since prior radiotherapy to the brain No prior high dose radiotherapy No prior stereotactic boost or implant radiotherapy Surgery: No prior surgery (except biopsy) for recurrent brain tumor At least 3 months since prior surgery for primary brain tumor Other: No other concurrent anticancer agents No other concurrent investigational therapy
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 una ubicación