Virus Therapy

Pharmacological Study for Anaplastic Astrocytoma

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
Karnofsky performance status >= 70%
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
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upup to 15 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group

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.

Eligible Conditions
  • Anaplastic Astrocytoma
  • Anaplastic Oligoastrocytoma
  • Oligodendroglioma
  • Glioblastoma
  • Gliosarcoma
  • Gliomas
  • Brain Tumor

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are able to perform daily activities and tasks with at least 70% efficiency.
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.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of all attributable toxicities graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Incidence of dose limiting toxicities (DLTs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Secondary outcome measures
Clinical benefit, defined by tumor response based on magnetic resonance imaging (MRI) results
Development of neural stem cells (NSC) immunogenicity after first and repeat exposures
Fate of the neural stem cells (NSCs), defined by NSC persistence
+1 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
Infusion related reaction
Neutrophil count decreased
Upper respiratory infection
Aspartate aminotransferase increased
Platelet count decreased
Alanine aminotransferase increased
Urinary tract infection
Tooth infection
Bronchial infection
Acute Coronary Syndrome
Febrile neutropenia
Infections and infestations - Other, specify
Nail infection
Rhinitis infective
Tumor lysis syndrome
Infusion Related Reaction
Wound infection
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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.
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Not yet FDA approved

Find a site

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
546 Previous Clinical Trials
2,252,217 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,412 Previous Clinical Trials
41,239,048 Total Patients Enrolled
Jana L PortnowPrincipal Investigator
City 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I qualify to participate in this research program?

"Currently, 18 individuals with glioma aged between 18 and 69 are eligible to apply for this clinical trial. Candidates must fulfill the following conditions: comprehension of written informed consent documents, having a Karnofsky performance status >= 70%, willingness to adhere to study/follow-up procedures, life expectancy > 3 months, histologically confirmed diagnosis of grade II - IV glioma (including but not limited to glioblastoma and anaplastic oligoastrocytoma), imaging evidence indicating recurrence or progression after previous radiation therapy + temozolomide treatment; if enrolling at dose level two or higher there"

Answered by AI

In what conditions are Pharmacological Studies most frequently prescribed?

"Pharmacological Study is a common intervention for treating malignant neoplasms of the pancreas. Additionally, this medication may aid in managing metastasis, gastric cancer, and rhabdomyosarcoma cases."

Answered by AI

To what extent can participating in a Pharmacological Study jeopardize patient safety?

"Our enterprise has assigned Pharmacological Study a score of 1 due to the limited data available surrounding its safety and efficacy as this is an initial-phase trial."

Answered by AI

What are the intended outcomes of this experiment?

"The aim of this 28 day clinical trial is to determine the frequency of adverse reactions as evaluated by the NCI CTCAE v4.0 while also monitoring other secondary objectives, such as patient response based on MRI results, NSC immunogenicity after first and repeat exposures, and ultimately measuring NSC persistence through descriptive statistics and graphical methods."

Answered by AI

Does this experiment have any available spaces for volunteers?

"Unfortunately, according to this trial is no longer searching for patients. Despite that being the case, it was initially posted on March 7th 2016 and last updated on June 7th 2022. Fortunately, there are still 1,885 other studies actively recruiting right now."

Answered by AI

How many individuals are being enrolled in this experimental study?

"Unfortunately, this trial is not currently open to new participants. It was first announced on March 7th 2016 and last updated on June 7th 2022. Nonetheless, if you are seeking out other medical studies, there are 1622 trials actively searching for glioma patients and 263 Pharmacological Studies welcoming volunteers."

Answered by AI

Could you please provide an overview of any past experimentation regarding Pharmacological Study?

"At present, 263 clinical trials related to Pharmacological Study are in progress with 53 of them being in their third phase. The most numerous concentration of these studies is located in Melbourne, Victoria but there are 8629 locations across the world running research for this particular study."

Answered by AI

Is this trial open to elderly participants?

"Patients of legal age (over 18) and under 69 are eligible for inclusion in this study."

Answered by AI
~0 spots leftby Dec 2023