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Recruiting Phase 1 NCT04323046

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

Trial Parameters

Condition Glioblastoma
Sponsor Sabine Mueller, MD, PhD
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 6 Months
Max Age 25 Years
Start Date 2020-10-02
Completion 2026-03-01
Interventions
NivolumabQuality-of-Life AssessmentQuestionnaire Administration

Brief 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.

Eligibility Criteria

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 participant and legal parent/guardian prior to enrollment 3. Have a history of previously treated histologically confirmed World Health Organization grade III or IV HGG. Previous first line therapy with radiation and/or chemotherapy 4. Have evidence of recurrence or progression of disease by MRI scan 5. Participants must be adequate medical candidates for surgical resection. The intent of surgical res

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