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Brief Title: Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
Official Title: Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
Study ID: NCT00331526
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Name: Robert O. Dillman, MD, FACP
Affiliation: Hoag Memorial Hospital Presbyterian
Role: STUDY_CHAIR