Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sabine Mueller, MD, PhD
Study ID
NCT04323046
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies, given in person or online
  • Questionnaire Administration — OTHER
    Ancillary studies, given in person or online

Study Details

This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Oct 2, 2020
Status verified
May 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant nivolumab and adjuvant nivolumab
    NEOADJUVANT: Patients receive nivolumab IV over 30 minutes 14 days before undergoing standard of care surgical resection. ADJUVANT MAINTENANCE: After completion of neoadjuvant infusion, patients receive nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage change in cell cycle-related genetic signature [ Time Frame: From screening to surgery visit (neoadjuvant treatment groups); at time of recurrent high grade glioma (HGG) tissue collection (for archived non-treated samples) ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham, Children's of AlabamaBirminghamAlabama35233
Girish Dhall, MD
[email protected]
205-638-9285
Katie Metrock, MD
[email protected]
Children's Hospital of Los AngelesLos AngelesCalifornia90027
Tom Davidson, MD
[email protected]
323-361-8147
Rady Children's HospitalSan DiegoCalifornia92123
Megan Paul, MD
[email protected]
University of California, San FranciscoSan FranciscoCalifornia94115
Sabine Mueller, MD, Phd
[email protected]
Sabine Mueller, MD (PRINCIPAL_INVESTIGATOR)
Children's National HospitalWashington D.C.District of Columbia20310
Lindsay Kilburn, MD
[email protected]
202-476-5973
University of FloridaGainesvilleFlorida32611
Elias Sayour, MD, PhD
[email protected]
352-294-8347
Riley Children's HospitalIndianapolisIndiana46202
Scott Coven, DO, MPH
[email protected]
317-944-8784
Scott Coven, DO, MPH (PRINCIPAL_INVESTIGATOR)
Runco Daniel, MD, MS (SUB_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Kenneth Cohen, MD, MBA
[email protected]
410-614-5055
Eric Raabe, MD
[email protected]
Dana Farber Cancer InstituteBostonMassachusetts02215
Susan Chi, MD
[email protected]
617-632-2291
Washington University St. LouisSt LouisMissouri63110
Mohamed Abdelbaki, MD
[email protected]
314-286-2790
Hackensack Meridian Children's Health at Joseph M. Sanzari Children's HospitalHackensackNew Jersey07601
Derek Hanson, MD
[email protected]
551-996-5437
Duke Children's Hospital & Health CenterDurhamNorth Carolina27705
Daniel Landi, MD, BS
[email protected]
919-684-8111
David Ashley, MBBS (Hon), FRACP, PhD
[email protected]
919-684-5580
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Cassie Kline, MD, MAS
[email protected]
267-426-5026
University of UtahSalt Lake CityUtah84113
Nicholas Whipple, MD
[email protected]
Priya Chan
[email protected]

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