A Single Arm, Pilot of Neoadjuvant Checkpoint Inhibition Followed by Adjuvant Checkpoint Inhibition in Children and Young Adults With Recurrent or Progressive High Grade Glioma (HGG)
Sabine Mueller, MD, PhD
Summary
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.
Description
PRIMARY OBJECTIVES: I. To measure the relative changes in cell cycle-related genetic signature of the tumor microenvironment post administration of neoadjuvant nivolumab in children and young adults with recurrent or progressive HGG when compared to a cohort of archived non-treated recurrent pediatric HGG samples. II. To characterize the safety and tolerability of neoadjuvant nivolumab followed by adjuvant nivolumab in children and young adults with recurrent or progressive HGG. SECONDARY OBJECTIVES: I. To determine the 6 month and 12 month overall survival (OS) in children and young adult…
Eligibility
- Age range
- 0–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants with recurrent or progressive high-grade gliomas (HGG) (World Health Organization (WHO) grade III or grade IV) who are candidates for surgical tumor debulking will be enrolled in this trial 2. All assessments are to occur within 14 days of registration except where otherwise noted. The participant and their legal parent/guardian must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the par…
Interventions
- BiologicalNivolumab
Given IV
- OtherQuality-of-Life Assessment
Ancillary studies, given in person or online
- OtherQuestionnaire Administration
Ancillary studies, given in person or online
Locations (20)
- University of Alabama at Birmingham, Children's of AlabamaBirmingham, Alabama
- Children's Hospital of Los AngelesLos Angeles, California
- Rady Children's HospitalSan Diego, California
- University of California, San FranciscoSan Francisco, California
- Children's National HospitalWashington D.C., District of Columbia
- University of FloridaGainesville, Florida