Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Gliom… (NCT04323046) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
United States, Australia9 participantsStarted 2020-10-02
Plain-language 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.
Who can participate
Age range
6 Months – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
. 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
. Have evidence of recurrence or progression of disease by MRI scan
. Participants must be adequate medical candidates for surgical resection. The intent of surgical resection is to allow both cytoreduction and tumor debulking as part of standard of care, and also collect a minimum of 100 mg of tumor tissue for the study tissue endpoints
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial that's no longer enrolling new patients — does that mean the results or safety data might be available soon, and could that information influence the treatment options you'd recommend for us?
2Since the trial is measuring changes in a 'cell cycle-related genetic signature,' does my child's or young adult's tumor need to be tested for specific genetic markers first, and is that kind of testing something we should pursue regardless of this trial?
3One of the main things this trial is tracking is treatment-related side effects from giving immunotherapy before and after surgery — given that we don't yet know the full safety profile from a Phase 1 study like this, how does that uncertainty compare to the risks of standard treatments you'd consider?
4Because this trial involves immunotherapy timed around a surgical procedure, how complex would the treatment schedule have been, and are there similar approaches being tested in trials that are still actively enrolling that we should look into?
5For a recurrent or progressive high-grade glioma like this, would you recommend exploring standard-of-care options first before pursuing an experimental immunotherapy approach, or do you feel the situation calls for something more investigational right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage change in cell cycle-related genetic signature
Timeframe: From screening to surgery visit (neoadjuvant treatment groups); at time of recurrent high grade glioma (HGG) tissue collection (for archived non-treated samples)
2
Proportion of participants with treatment-related adverse events
. A primary goal of surgery must be cytoreduction, and not solely on diagnostic biopsy
. Age: Participants must be \> 6 months and \< 25 years of age at time of enrollment
. Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants =\< 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
Exclusion criteria
. Current or planned participation in a study of an investigational agent or using an investigational device.
. Has a diagnosis of immunodeficiency.
. Has tumor primarily localized to the brainstem or spinal cord.
. Has presence of diffuse leptomeningeal disease or or disseminated/multi-focal disease, or extracranial disease.
. Has received systemic immunosuppressive treatments (such as methotrexate, chloroquine, azathioprine, etc.), aside from anti-neoplastic chemotherapy or systemic corticosteroids within six months of registration.
. Participants with a concurrent condition requiring systemic treatment with either corticosteroids (\> 0.25 mg/kg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 0.25 mg/kg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
. Unable to taper steroids due to ongoing mass effect; a maximum dexamethasone dose of 0.1 mg/kg/day is allowed (4mg maximum), but preferably have been discontinued (inhaled or topical use of steroids is allowed).
. Has a known history of active TB (Bacillus tuberculosis).