Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Side effects and toxicity
Robert O. Dillman, MD, FACP
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
United States: Food and Drug Administration
|Hoag Cancer Center at Hoag Memorial Hospital Presbyterian||Newport Beach, California 92663|