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

Completed · Phase 1

Conditions studied: Anaplastic Astrocytoma, Anaplastic Ependymoma, Anaplastic Meningioma, Anaplastic Oligodendroglioma, Brain Stem Glioma, Ependymoblastoma, Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma, Grade III Meningioma, Meningeal Hemangiopericytoma, Mixed Glioma, Pineal Gland Astrocytoma, Brain Tumor

In brief

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.

Key facts

Study ID: NCT01082926
Run by: City of Hope Medical Center
People needed: 6
Starts: 2010-05-01
Expected to finish: 2013-09-01
Last updated by the study team: 2015-06-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histological verification of grade III or IV MG at original diagnosis
Radiographic evidence of progression/recurrence of the measurable disease more than 12 weeks after the end of radiation therapy
Expression of IL13Ralpha2 by immunohistochemistry
Karnofsky performance status (KPS) >= 60
Disease recurrence/progression in the cerebral hemisphere, which is in at least one area of enhancement amenable to biopsy after protocol enrollment in the following locations:
Adjacent or near previous resection cavity
Distant from primary location; this includes tumor spread to contralateral hemisphere, corpus callosum, thalamus, basal ganglion, or subependymal locations
Research participant has recovered from toxicity of prior therapies; an interval of at least 12 weeks must have elapsed since the completion of radiation therapy; at least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen; and at least 4 weeks since the completion of a non-nitrosourea-containing cytotoxic chemotherapy regimen; if a patient's most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of study treatment, with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting study treatment
History of prior treatment with Temodar if no evidence of intolerance; documentation of intolerance to Temodar is not required
Creatinine < 1.6
White blood cell (WBC) >= 2,000/dl (or absolute neutrophil count [ANC] > 1,000) Platelets >= 100,000/dl unsupported by transfusion or growth factor, international normalized ratio (INR) < 1.3
Bilirubin < 1.5
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) < 2 X upper limits of normal
Female research participants of childbearing potential must not be pregnant as evidenced by a serum beta-HCG pregnancy test obtained within 7 days of enrollment
Research participants having reproductive potential must agree to use effective contraception during participation on this protocol
In the opinion of the neurosurgeon, research participant requires on-going dexamethasone therapy

You may not qualify if…

Survival expectation less than 4 weeks
Pulmonary- Requirement for supplemental oxygen use that is not expected to resolve within 2 weeks, Cardiac- Uncontrolled cardiac arrhythmia, hypotension requiring pressor support, Renal- Dialysis dependent, Neurologic- refractory seizure disorder, clinically evident progressive encephalopathy
Tumors with the following characteristics:
Large tumor recurrence causing significant symptoms from brain shift or mass effect, and thus not requiring "decompressive" craniotomy
Tumors located primarily in the basal ganglion or thalamus
Tumors with significant involvement of midbrain, cerebellum, pons and medulla will be excluded due to neurological risks associated with edema exacerbation from therapy
Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
Positive human immunodeficiency virus (HIV) serology based on testing within 4 weeks of enrollment
Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
Failure to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study
History of ganciclovir and/or magnetic resonance imaging (MRI) contrast allergy or intolerance History of intolerance to IL-2

Where it is running

City of Hope — Duarte, California, United States

Full record on ClinicalTrials.gov

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