Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme

Hoag Memorial Hospital Presbyterian83 enrolled

Overview

RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells, including lymphokine-activated killer cells, to kill tumor cells. Giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in treating patients with glioblastoma multiforme.

OBJECTIVES: * Determine the feasibility, side effects, and toxicity associated with intracranial cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated killer cells in patients with glioblastoma multiforme. * Determine progression-free and overall survival of these patients. * Compare survival of these patients to that of contemporary and historical controls. OUTLINE: Patients undergo therapeutic craniotomy. Patients undergo leukapheresis to obtain lymphokine-activated killer (LAK) cells 3-7 days before therapeutic craniotomy OR 4-6 weeks after therapeutic craniotomy. Patients receive cellular adoptive immunotherapy comprising aldesleukin-stimulated LAK cells intracranially at the time of therapeutic craniotomy OR via an Ommaya reservoir (placed during craniotomy) no sooner than 4-6 weeks after therapeutic craniotomy. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain and Central Nervous System Tumors

Interventions

aldesleukinBIOLOGICAL

therapeutic autologous lymphocytesBIOLOGICAL

adjuvant therapyPROCEDURE

conventional surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of primary malignant glioblastoma multiforme (i.e., grade IV anaplastic astrocytoma) * Primary treatment (surgery, radiation, and/or chemotherapy) has been completed * Candidate for surgery and willing to undergo craniotomy * No progressive or recurrent disease * No residual disease that requires reoperation, additional gamma therapy, or other modality PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% (i.e., if symptomatic, bedridden \< half of a waking day) * Life expectancy ≥ 2 months * Not pregnant * Negative pregnancy test * U.S. residents only * No hematopoietic, hepatic, renal, cardiovascular, or pulmonary laboratory values or other medical circumstances that would preclude surgery or aldesleukin therapy * No serious concurrent medical or psychiatric illness that would preclude informed consent or study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior anticancer therapy and recovered * Prior stereotactic or gamma knife radiosurgery allowed

Locations (1)

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Outcomes

Primary Outcomes

Side effects and toxicity

Progression-free survival and overall survival

Data from ClinicalTrials.gov

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