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

Timeline

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

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You are able to perform daily activities and tasks with at least 70% efficiency.

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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.

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According to the neurosurgeon's assessment, there is no expected direct connection between the surgical cavity and the fluid-filled spaces in the brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

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

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

Bronchial infection

Acute Coronary Syndrome

Febrile neutropenia

Sepsis

Infections and infestations - Other, specify

Nail infection

Rhinitis infective

Tumor lysis syndrome

Infusion Related Reaction

Wound infection

100%

80%

60%

40%

20%

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

FDA approved

Camptothecin

Not yet FDA approved

0 / 3Eligibility criteria met

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 clinicaltrials.gov 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