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
Active Not Recruiting

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

First listed
Mar 26, 2020
Start date
Oct 2, 2020
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
9 participants (actual)
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) ]

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham, Children's of AlabamaBirminghamAlabama35233-
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
Rady Children's HospitalSan DiegoCalifornia92123-
University of California, San FranciscoSan FranciscoCalifornia94115-
Children's National HospitalWashington D.C.District of Columbia20310-
University of FloridaGainesvilleFlorida32611-
Riley Children's HospitalIndianapolisIndiana46202-
Johns Hopkins UniversityBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Washington University St. LouisSt LouisMissouri63110-
Hackensack Meridian Children's Health at Joseph M. Sanzari Children's HospitalHackensackNew Jersey07601-
Duke Children's Hospital & Health CenterDurhamNorth Carolina27705-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
University of UtahSalt Lake CityUtah84113-

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Alabama at Birmingham, Children's of Alabama· Birmingham, ALChildren's Hospital of Los Angeles· Los Angeles, CARady Children's Hospital· San Diego, CAUniversity of California, San Francisco· San Francisco, CAChildren's National Hospital· Washington D.C., DCUniversity of Florida· Gainesville, FL

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