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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

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

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 • NCT03010358

33%

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%

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