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Stem cells could help chemo target brain tumors
NCT ID NCT02192359
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new approach for people with aggressive brain tumors that have come back. Doctors place genetically modified neural stem cells directly into the tumor to make it more sensitive to the chemotherapy drug irinotecan. The study involves 18 participants and focuses on safety and finding the best dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- genetically modified neural stem cells and irinotecan chemotherapy
- What this could lead to
- If it works, this could point toward a new way to treat aggressive brain tumors by making them more sensitive to chemotherapy.
- What could go wrong
- This is a very early phase I safety trial with only 18 people. The approach is experimental, may not work, and carries risks like brain swelling or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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18 people
The number who actually took part.
- Started
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Apr 2016
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 69 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient must be able to understand and be willing to sign a written informed consent document * Participant must be willing to comply with study and/or follow-up procedures * Karnofsky performance status \>= 70% * Life expectancy of \>= 3 months * Histologically-confirmed diagnosis of a grade III or IV glioma (including glioblastoma, anaplastic astrocytoma, gliosarcoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma), or has a prior, histologically-confirmed, diagnosis of a grade II glioma and now has radiographic findings consistent with a high-grade glioma (grade III or IV) * Imaging studies show evidence of recurrent tumor(s); if a patient is going to be enrolled to dose level two or higher, the patient must have a component of supratentorial disease (so as to enable placement of a Rickham reservoir/catheter) that is amenable to resection or biopsy * High-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide * Participant must be in need of a craniotomy for tumor resection or a stereotactic brain biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy +/- chemotherapy * Based on the neurosurgeon?s judgment, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles * Neurosurgeon finds the prospective participant is able to undergo neurosurgery * Any number of prior therapies is permitted; from the start of study treatment, the following time periods must have elapsed: 6 weeks from nitrosourea-containing chemotherapy, 4 weeks from non-nitrosourea-containing cytotoxic chemotherapy (except 23 days from last daily dose of temozolomide taken in a 5 of 28 day regimen), and 2 weeks from last dose of a targeted agent (except 4 weeks for bevacizumab); there is no time period requirement for prior radiation therapy * Any clinically significant toxicity from prior therapy must have improved to grade 0 or grade 1 * Absolute neutrophil count (ANC) \>= 1,500 cells/ul * Platelets \> 100,000 cells/ul * Total bilirubin =\< 2.0 mg/dl * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 4 times institutional upper limit of normal * Serum creatinine =\< 1.5 x the institutional upper limit of normal * Homozygous negative for the UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT 1A1)\*28 allele * Absence anti-human leukocyte antigen (HLA) antibodies specific for HLA class I antigens expressed by the coagulation factor III (thromboplastin, tissue factor) (F3).cytosine deaminase (CD).carboxylesterase (CE) NSCs * Negative serum pregnancy test (women of childbearing potential only) * Agreement by females of childbearing potential and sexually active males to use an effective method of contraception while participating in this study; women of childbearing potential must have a negative pregnancy test \< 2 weeks prior to registration Exclusion Criteria: * Prior therapy with neural stem cells * Use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers including hepatic enzyme-inducing anticonvulsants (phenytoin, fosphenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) within 2 weeks prior to start of study treatment * Use of moderate to strong CYP3A4 inhibitors within 2 weeks prior to start of study treatment * Use of drugs known to inhibit UGT1A1, such as atazanir, gemfibrozil, indinavir, or ketoconazole, within 2 weeks prior to start of study treatment * Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrolimus; consult principal investigator for questions, including necessary washout period for the specific drug * Flucytosine within 2 weeks prior to start of study treatment * Use of herbal medications * Current use (or planned use during the treatment period) of other investigational agents, or biological, chemotherapy, radiation or other anti-tumor therapy * Patient has known human immunodeficiency virus (HIV) or hepatitis C infection; baseline testing for HIV or hepatitis C is not required * Prospective participant is unable to undergo a magnetic resonance imaging (MRI) with contrast agent * Known chronic or active viral infections of the central nervous system (CNS) * Clinically significant uncontrolled illness * Active infection requiring antibiotics * Diagnosis of Gilbert?s disease * History of allergic reactions attributed to compounds of similar chemical or biologic composition to irinotecan * Known sensitivity to any of the products to be administered during dosing * Any other active malignancy * Pregnant women and women who are lactating * Serious medical or psychiatric illness that could, in the investigator?s opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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Other studies related to the condition(s) this trial covers.
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