Pediatric Brain Tumor Clinical Trial
Official title:
A Phase I Study of Intra-Tumoral Injections of Ex Vivo Expanded Natural Killer Cells in Children and Young Adults With Recurrent or Progressive Supratentorial Malignant Brain Tumors
This phase I trial tests the safety, side effects, and best dose of ex vivo expanded natural killer cells in treating patients with cancerous (malignant) tumors affecting the upper part of the brain (supratentorial) that have come back (recurrent) or that are growing, spreading, or getting worse (progressive). Natural killer (NK) cells are immune cells that recognize and get rid of abnormal cells in the body, including tumor cells and cells infected by viruses. NK cells have been shown to kill different types of cancer, including brain tumors in laboratory settings. Giving NK cells from unrelated donors who are screened for optimal cell qualities and determined to be safe and healthy may be effective in treating supratentorial malignant brain tumors in children and young adults.
PRIMARY OBJECTIVES: I. To determine the safety and tolerability of natural killer (NK) cells that have been propagated ex vivo with genetically-modified feeder cells and administered intra-tumoral via an Ommaya reservoir in patients with recurrent or progressive supratentorial malignant brain tumors. II. To determine the recommended phase 2 dose (RP2D) for natural killer (NK) cells that have been propagated ex vivo with genetically-modified feeder cells and administered intra-tumoral via an Ommaya reservoir in patients with recurrent or progressive supratentorial malignant brain tumors. EXPLORATORY OBJECTIVES: I. To determine the 6 months overall survival (OS), defined as the percentage of patients in the study who are alive at 6 months following start of treatment. II. To determine the persistence, immuno-phenotype and function of adoptively-transferred expanded NK cells, and correlate the findings with the overall response. III. To determine the immune signature-based profile of each patient's tumor. IV. To determine changes in the T-cell receptor (TCR) repertoire diversity before and after Transforming growth factor beta imprinted (TGFβi) NK cell treatment. V. To evaluate the effect of systemic steroids on the persistence and efficacy of TGFβi NK cells. VI. To assess Quality of Life (QOL) and cognitive measures in children and young adults with recurrent or progressive supratentorial malignant brain tumors. OUTLINE: This is a dose-escalation study. Participants undergo placement of an Ommaya reservoir and receive universal donor expanded TGF-beta-imprinted NK cells (TGFBi NK cells) intratumorally via Ommaya reservoir in 4-week cycles. Infusions via Ommaya will occur once weekly for three weeks followed by one week of rest. If patients have stable or improved disease, patients may continue to receive therapy for a total of 12 cycles. Participants will be followed for 5 years after completion of treatment, or until removal from study or death, whichever comes first. ;
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