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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
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ until death or disease progression, a median of 2 months, up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death or disease progression, a median of 2 months, up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 • NCT0301035833%
Infusion Related Reaction
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
17%
Sinusitis
17%
Tumor Lysis Syndrome
17%
Interoperative Hemorrhage
17%
Platelet count decreased
17%
Febrile neutropenia
17%
Infusion related reaction
17%
Upper respiratory infection
17%
Otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Phase 2 and MTD (800 mg Entospletinib Daily)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2050
Irinotecan
2017
Completed Phase 3
~2590
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,429 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,152 Total Patients Enrolled
Jana L PortnowPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking herbal medications.You have received treatment with neural stem cells in the past.You are able to perform daily activities and tasks with at least 70% efficiency.You have a serious illness that is not well controlled.You currently have an infection that needs antibiotics.You have experienced allergic reactions to drugs that are similar to irinotecan.You are allergic or sensitive to any of the medications that will be given to you during the study.You need to have surgery to remove a brain tumor or have a brain biopsy to determine if the tumor is growing or if it's a side effect of radiation therapy or chemotherapy.According to the neurosurgeon's assessment, there is no expected direct connection between the surgical cavity and the fluid-filled spaces in the brain.You have any other type of cancer that is currently active.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.