Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT02192359
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Recurrent Anaplastic Astrocytoma
  • Recurrent Anaplastic Oligoastrocytoma
  • Recurrent Anaplastic Oligodendroglioma
  • Recurrent Glioblastoma
  • Recurrent Gliosarcoma
  • Recurrent Malignant Glioma
  • Recurrent WHO Grade III Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboxylesterase-expressing Allogeneic Neural Stem Cells — BIOLOGICAL
    Given intracranially
  • Irinotecan — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of carboxylesterase-expressing allogeneic neural stem cells when given together with irinotecan hydrochloride in treating patients with high-grade gliomas that have come back. Placing genetically modified neural stem cells into brain tumor cells may make the tumor more sensitive to irinotecan hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.

Key Dates

Start date
Apr 5, 2016
Status verified
Apr 2026
Primary completion
Feb 21, 2022
Completion
Sep 25, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
    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.

Primary Outcome Measure

Number of Participants Experiencing a Dose-limiting Toxicity (DLT) [ Time Frame: 28 days post first dose of NSC treatment on day 1, cycle 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

Find similar trials in Duarte, CA

By condition
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By specialty
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By research site
City of Hope Medical Center· Duarte, CA

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