Biological Therapy in Treating Patients With Primary or Advanced Glioma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Biological: aldesleukin
* Biological: lymphokine-activated killer cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: lymphokine-activated killer cells|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma