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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-06-08

No results posted yet for this study

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.

Conditions

  • 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

Interventions

BIOLOGICAL

therapeutic allogeneic lymphocytes

Given intratumorally

BIOLOGICAL

aldesleukin

Given intratumorally

OTHER

laboratory biomarker analysis

Optional correlative studies

PROCEDURE

positron emission tomography

Optional correlative studies

Sponsors & Collaborators

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Behnam Badie · City of Hope Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01082926 on ClinicalTrials.gov