drugset
drugset / Trial / NCT01082926

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

NCT01082926 ↗

Phase 1 Completed 6 enrolled City of Hope Medical Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-05
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject GRm13Z40-2 Cell therapy — Other
Subject aldesleukin Protein / enzyme biologic — Other

Indications

anaplastic astrocytoma anaplastic ependymoma anaplastic meningioma anaplastic oligodendroglioma brain stem glioma ependymoblastoma giant cell glioblastoma gliosarcoma meninges hemangiopericytoma mixed glioma pineal gland astrocytoma