Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme
carmustine
+ radiation therapy
Astrocitoma+8
+ Glioma
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the feasibility and toxicity of escalating doses of conformal radiotherapy planned with 3-D treatment planning plus carmustine in patients with glioblastoma multiforme. Determine dose/volume and dose/anatomic characteristics that influence radiotherapy-induced CNS (central nervous system) toxicity. Evaluate local control, survival, and failure patterns of these patients treated with high doses of conformal radiotherapy to gross disease. Correlate changes on cross-sectional diagnostic MRI imaging studies to clinical or biologic endpoints. OUTLINE: This is a dose-escalation study. Patients are stratified according to the planned target volume, i.e., gross residual tumor plus 3 mm (less than 75 cc vs at least 75 cc). Patients undergo radiotherapy over 15-30 minutes daily 5 days a week for 6-8 weeks. After 46 Gy of radiotherapy have been administered, patients undergo radiotherapy field reduction and are accrued into one of four dose levels. (Dose level 1 closed to accrual 1/16/01) All patients receive at least 33 radiation treatments. Each patient is evaluated for acute dose-limiting toxicity for 90 days from start of therapy. Patients also receive carmustine IV over 1-2 hours daily on days 1-3 for the first week of radiotherapy. Treatment repeats every 8 weeks for up to 6 courses. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within at least 5 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 40 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 confirmed glioblastoma multiforme with areas of necrosis as diagnosed by surgical biopsy or subtotal excision Supratentorial tumor Gross measurable residual disease No well-differentiated or anaplastic astrocytoma, multifocal glioma, or recurrent glioblastoma multiforme Therapy must begin within 5 weeks after surgery but within 1 week after registration CT or MRI scan preoperatively and MRI postoperatively prior to initiation of radiotherapy If undergoing a stereotactic-guided needle biopsy, not required to repeat MRI after procedure if the prebiopsy MRI is suitable for treatment planning Prior complete surgical resection of tumor allowed 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/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL SGPT (serum glutamate pyruvate transaminase) or SGOT (serum glutamic oxaloacetic transaminase) no greater than 2 times normal Renal: BUN (blood urea nitrogen) no greater than 30 mg/dL Creatinine no greater than 1.8 mg/dL Pulmonary: Normal chest x-ray OR DLCO (carbon monoxide diffusing capacity) at least 60% predicted Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer Neurologic functional status 0-3 No major medical illness or psychiatric impairments that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head or neck Surgery: See Disease Characteristics
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 237 ubicaciones
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesAbrir University of Alabama at Birmingham Comprehensive Cancer Center en Google MapsComprehensive Cancer Institute of Huntsville
Huntsville, United StatesHuntsville Hospital System
Huntsville, United StatesMBCCOP - Gulf Coast
Mobile, United States