biological therapy in treating patients with primary or advanced glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma. purpose: clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.

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.

Eligibility criteria:
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

Keywords: recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult mixed glioma adult giant cell glioblastoma adult gliosarcoma