Genetically Modified Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
NCT02055196 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2014-06-02
Summary
This phase I trial studies the side effects and best dose of genetically modified stem cells when given together with irinotecan hydrochloride in treating patients with recurrent high-grade gliomas. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Placing a gene that has been created in the laboratory into neural stem cells and injecting it into the brain may help irinotecan hydrochloride kill more tumor cells once it reaches the brain.
Conditions
- Adult Anaplastic Astrocytoma
- Adult Anaplastic Oligodendroglioma
- Adult Giant Cell Glioblastoma
- Adult Glioblastoma
- Adult Gliosarcoma
- Recurrent Adult Brain Tumor
Interventions
- BIOLOGICAL
-
carboxylesterase-expressing allogeneic neural stem cells
Given via intracerebral catheter
- DRUG
-
irinotecan hydrochloride
Given IV
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Jana Portnow · City of Hope Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Primary Completion
- 2014-05-31
Countries
- United States
Study Locations
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