Glioblastoma Clinical Trial
Official title:
Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the
immune system in different ways and stop tumor cells from growing. Donor T cells that are
treated in the laboratory may be effective treatment for malignant glioma. Aldesleukin may
stimulate the white blood cells to kill tumor cells. Combining different types of biological
therapies may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best way to give therapeutic
donor lymphocytes together with aldesleukin in treating patients with stage III or stage IV
malignant glioma.
PRIMARY OBJECTIVES:
I. To assess the safety of GRm13Z40-2 CTL CNS loco-regional cellular immunotherapy in
research participants with recurrent or refractory/ progressive malignant glioma (WHO Grades
3 or 4).
II. To assess the safety of convection enhanced delivery (CED) of recombinant human
Interleukin-2 (rhuIL-2) used in conjunction with GRm13Z40-2 CTL adoptive transfer.
SECONDARY OBJECTIVES:
I. To investigate the ability of 9-(4-fluoro-3-hydroxy-methyl-butyl) guanine (18FHBG)
positron emission tomography PET to image GRm13Z40-2 CTL's in research participants.
II. To study the impact of concurrent dexamethasone administration on the tempo and
magnitude of T cell allograft rejection responses in treated research participants by
tracking the frequency of anti-GRm13Z40-2 immune responses in serially acquired peripheral
blood samples.
III. To evaluate ganciclovir administration for ablating transferred GRm13Z40-2 in vivo
should significant graft-mediated toxicities be encountered.
OUTLINE: Patients receive GRm13Z40-2 therapeutic allogeneic lymphocytes intratumorally (IT)
over 10 minutes on days 1 and 3 and aldesleukin IT over 3 hours on days 2-5 (days 1-5 in
week 2). Treatment repeats every week for 2 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed annually for at least 15 years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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