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NCT01082926 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Glioblastoma and Gliosarcoma, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01082926 is a Phase 1 study of Glioblastoma and Gliosarcoma that has completed, run by City of Hope Medical Center. The registered enrollment target is 6 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01082926, a Phase 1 study of Glioblastoma and Gliosarcoma, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- OTHER laboratory biomarker analysis
- PROCEDURE positron emission tomography
- BIOLOGICAL aldesleukin
- BIOLOGICAL therapeutic allogeneic lymphocytes
Study Locations (1)
California
- City of Hope - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01082926
The ClinicalTrials.gov registry entry for NCT01082926 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (94% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01082926 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01082926 about?
NCT01082926 is a clinical study titled "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 c...
What is the current status of trial NCT01082926?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2010-05. Estimated completion is 2013-09.
What conditions does trial NCT01082926 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Ependymoma.
What interventions are being tested in trial NCT01082926?
The interventions under investigation include: laboratory biomarker analysis (OTHER), positron emission tomography (PROCEDURE), aldesleukin (BIOLOGICAL), therapeutic allogeneic lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01082926?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01082926 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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