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Clinical Trial 18752
Cancer Type: Neurologic Oncology
Study Type: Treatment
NCT#: NCT03334305
Phase: Phase I
Prinicipal Investigator: Damon Reed
Study Title
ACTION Trial- Adoptive Cellular Therapy following Dose-Intensified Temozolomide in Newly-diagnosed Pediatric High-grade Gliomas (Phase I)
Summary
The purpose of this research study is to learn whether anti-tumor T-cells and anti-tumor DC vaccines can be given safely. Most importantly, this study is also to determine whether the T-cells and DC vaccines can stimulate a person's immune system to fight off the tumor cells in the brain.
Objective
To determine the safety of adoptive cellular therapy in pediatric patients with HGG receiving dose intensified TMZ and DC+xALT therapy with and without HSCs. 1) Examine feasibility of completing treatment (administration of at least 3 DC vaccines) in enrolled subjects. 2) Comparison of baseline to post-immunotherapy functional anti-tumor immune responses. 3) Analysis of progression-free survival and overall survival after treatment with DC + xALT therapy with and without HSCs.
Therapies
Medications
Autologous Dendritic Cells (); Autologous Lymphocyte Infusion (); Hematopoietic Progenitor Cells (); Temodal (Temozolomide); Temozolomide ()
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