Brain and Central Nervous System Tumors Clinical Trial
Official title:
Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas
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.
;
Primary Purpose: Treatment
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