Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
carmustine
+ topotecan hydrochloride
Enfermedades del Cerebro+4
+ Enfermedades del Sistema Nervioso Central
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine. Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma. OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week. Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional 3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients. Patients are evaluated after every 6 week cycle. PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 36 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 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 proven recurrent primary malignant glioma Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky at least 60% Hematopoietic: Hematocrit greater than 29% ANC greater than 1,500/mm^3 Platelet count greater than 125,000/mm^3 Hepatic: SGOT less than 1.5 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine less than 1.5 mg/dL BUN less than 25 mg/dL Other: Not pregnant Effective contraceptive method must be used for the duration of the study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 6 weeks of study No prior topotecan or carmustine treatment failure No more than 1 prior chemotherapy regimen Endocrine therapy: Patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level Radiotherapy: No prior radiotherapy within 6 weeks of study Surgery: No prior surgical resection within 3 weeks of study Other: No concurrent medication that may interfere with study results
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 MapsSaint Jude Children's Research Hospital
Memphis, United States