Biological Therapy in Treating Patients With Primary or Advanced Glioma

Weill Medical College of Cornell University

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Brain and Central Nervous System Tumors

Interventions

aldesleukinBIOLOGICAL

lymphokine-activated killer cellsBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Staten Island University Hospital

Staten Island, New York, United States

Data from ClinicalTrials.gov

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