Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas
aldesleukin
+ lymphokine-activated killer cells
Enfermedades del Cerebro+11
+ Enfermedades del Sistema Nervioso Central
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary, recurrent or refractory malignant gliomas. Determine whether the induction of a regional, intracavitary, eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients. OUTLINE: Patients receive cytoreductive tumor surgery and/or biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction. Patients undergo outpatient leukapheresis on day -4 or -5, and cells are incubated ex vivo with interleukin-2 (IL-2). Lymphokine-activated killer (LAK) cells and IL-2 are infused on day 1. Bolus infusions of low-dose IL-2 are administered on days 3, 5, 8, 10, and 12, followed by a rest period on days 13-24. The course is repeated on day 25 starting with leukapheresis. Therapy courses are repeated for up to 1 year for stable disease or response to therapy. Maintenance doses repeat every 4-6 months thereafter. Disease restaging is done every 8-12 weeks. PROJECTED ACCRUAL: A total of 30 patients per year will be enrolled.
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 radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma) Must be a candidate for neurosurgical biopsy or tumor debulking PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Life Expectancy: Greater than 4 months Hematopoietic: Granulocytes greater than 1,500/mm^3 Platelet count greater than 50,000/mm^3 PT and PTT within normal limits Hepatic: Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: No congestive heart failure No coronary artery disease No serious cardiac arrhythmias No prior myocardial infarction Pulmonary: No major pulmonary problems Other: No history of neurologic disease (except related to brain tumor) No psychosis No impaired cognitive function No significant concurrent medical illness No active infection requiring antibiotic therapy Not pregnant Negative pregnancy test Fertile patients must use effective contraception Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device No hepatitis B or C HIV negative No prior autoimmune disease Allergy to gentamicin is allowed PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy and recovered No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered No concurrent chemotherapy Endocrine therapy: Reduction or elimination of corticosteroids Not greater than 0.15 mg/kg/day dexamethasone equivalent Radiotherapy: At least 6 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Prior surgery is allowed Other: Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed
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
Staten Island University Hospital
Staten Island, United StatesAbrir Staten Island University Hospital en Google Maps