Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas
aldesleukin
+ lymphokine-activated killer cells
Maladies du cerveau+15
+ Maladies du système nerveux central
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1997
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Staten Island University Hospital
Staten Island, United StatesOuvrir Staten Island University Hospital dans Google Maps