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Virus Therapy

Stem Cell Therapy + Chemotherapy for Brain Tumor

Phase 1
Waitlist Available
Led By Jana L Portnow
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death or disease progression, a median of 2 months, up to 6 months
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of carboxylesterase-expressing allogeneic neural stem cells given with irinotecan hydrochloride for high-grade gliomas. The hope is that the genetically modified neural stem cells will make the tumor more sensitive to the irinotecan hydrochloride, which may stop the growth of the tumor cells.

Who is the study for?
This trial is for patients with recurrent high-grade brain tumors like glioblastoma or astrocytoma, who have already tried standard treatments. They must be in good enough health to understand the study and undergo surgery, with a life expectancy of at least 3 months. Participants can't join if they've had neural stem cell therapy before, are on certain drugs that affect the treatment, or have infections like HIV.Check my eligibility
What is being tested?
The trial tests genetically modified neural stem cells combined with irinotecan hydrochloride against high-grade gliomas. The goal is to see if this combo makes the cancer more sensitive to treatment and stops tumor growth by blocking key enzymes needed by cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation, such as inflammation in various organs; typical chemotherapy-related issues like nausea and fatigue; blood count changes leading to increased infection risk; and potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death or disease progression, a median of 2 months, up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death or disease progression, a median of 2 months, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
Number of Participants With Grade 3 or Higher Toxicity Profile Attributed to Irinotecan
Number of Participants With Grade 3 or Higher Toxicity Profile Attributed to NSCs
Secondary outcome measures
Median Ratio of SN-38 AUC to CPT-11 AUC in the Brain
Median Ratio of SN-38 Area Under the Curve (AUC) to CPT-11 AUC in Plasma
Number of Participants With Clinical Benefit Defined by Response Assessment in Neuro-Oncology (RANO)

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)Experimental Treatment5 Interventions
Patients receive carboxylesterase-expressing allogeneic neural stem cells intracranially over 1.5-4.5 hours on days 1 and 15 (day 1 only for patients at dose level 1) and irinotecan hydrochloride IV over 90 minutes on days 3 and 17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Irinotecan
2017
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,598 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,346 Total Patients Enrolled
Jana L PortnowPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Carboxylesterase-expressing Allogeneic Neural Stem Cells (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02192359 — Phase 1
Anaplastic Astrocytoma Research Study Groups: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
Anaplastic Astrocytoma Clinical Trial 2023: Carboxylesterase-expressing Allogeneic Neural Stem Cells Highlights & Side Effects. Trial Name: NCT02192359 — Phase 1
Carboxylesterase-expressing Allogeneic Neural Stem Cells (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02192359 — Phase 1
~2 spots leftby Jun 2025
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