Actively Recruiting
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
Led by Sabine Mueller, MD, PhD · Updated on 2025-05-04
20
Participants Needed
20
Research Sites
438 weeks
Total Duration
On this page
Sponsors
S
Sabine Mueller, MD, PhD
Lead Sponsor
P
Pediatric Neuro-Oncology Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have recurrent or progressive high-grade glioma (WHO grade III or IV) and be eligible for surgical tumor removal
- Participants and their guardians must give informed consent and understand study requirements
- Histologically confirmed WHO grade III or IV HGG with prior treatment including radiation and/or chemotherapy
- Evidence of tumor recurrence or progression by MRI
- Medically suitable for surgery intended for tumor cytoreduction and to obtain at least 100 mg of tumor tissue
- Surgery goal must be tumor reduction, not just biopsy
- Age between greater than 6 months and less than 25 years at enrollment
- Karnofsky or Lansky performance score of at least 50 depending on age
- Stable neurological deficits for at least 1 week prior to enrollment with documented baseline exam
- Fully recovered from prior anticancer therapy with required waiting periods after chemotherapy, radiation, biologics, antibodies, and stem cell infusions
- Willing to avoid other cytotoxic anti-tumor treatments during study therapy
- Adequate organ function including specific blood counts, kidney function, liver enzymes, and serum albumin levels
- Women of childbearing potential must agree to use effective contraception during and 5 months after treatment
- MRI performed within 28 days before registration
You will not qualify if you...
- Participation in other investigational studies or use of investigational devices
- Diagnosis of immunodeficiency
- Tumor primarily located in brainstem or spinal cord
- Presence of diffuse leptomeningeal, multifocal, or extracranial disease
- Use of systemic immunosuppressive treatments other than chemotherapy or corticosteroids within 6 months
- Need for systemic corticosteroids over 0.25 mg/kg prednisone equivalent or immunosuppressants within 14 days before treatment
- Inability to taper steroids to allowed doses
- Known active tuberculosis
- Other active malignancies requiring treatment within 3 years, except certain skin or cervical cancers
- Active autoimmune disease treated systemically in past 2 years
- History or evidence of active non-infectious pneumonitis
- Active infections requiring systemic therapy
- Known allergy to study drugs
- Positive HIV, hepatitis B or C tests indicating active infection
- Prior allogenic stem cell transplant
- Serious uncontrolled medical conditions increasing study risk or interfering with treatment or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham, Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
4
University of California, San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
5
Children's National Hospital
Washington D.C., District of Columbia, United States, 20310
Actively Recruiting
6
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
7
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Washington University St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Hackensack Meridian Children's Health at Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States, 07601
Actively Recruiting
12
Duke Children's Hospital & Health Center
Durham, North Carolina, United States, 27705
Actively Recruiting
13
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
University of Utah
Salt Lake City, Utah, United States, 84113
Actively Recruiting
15
Sydney Children's Hospital
Sydney, New South Wales, Australia, 1291
Actively Recruiting
16
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2152
Actively Recruiting
17
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
18
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
19
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
20
Perth Children's' Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
J
Jannerfer An
CONTACT
S
Sabine Mueller, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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