NCT02192359Active, not recruitingPhase 1
Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas
A Phase I Study of Intracranially Administered Carboxylesterase-Expressing Neural Stem Cells in Combination With Intravenous Irinotecan in Patients With Recurrent High-Grade Gliomas
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
This phase I trial studies the side effects and best dose of carboxylesterase-expressing allogeneic neural stem cells when given together with irinotecan hydrochloride in treating patients with high-grade gliomas that have come back. Placing genetically modified neural stem cells into brain tumor cells may make the tumor more sensitive to irinotecan hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 15 Jul 2014
- Start date
- 5 Apr 2016
- Primary completion date
- 21 Feb 2022
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Glioblastoma
- NCT number
- NCT02192359
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 18
- From 5 Apr 2016 to the primary completion date, 21 Feb 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patient has known human immunodeficiency virus (HIV) or hepatitis C infection; baseline testing for HIV or hepatitis C is not required
- 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
- Any other active malignancy
- 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
Other
- Prospective participant is unable to undergo a magnetic resonance imaging (MRI) with contrast agent
- Known sensitivity to any of the products to be administered during dosing
- Pregnant women and women who are lactating
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.