Poly-ICLC for Low-Grade Glioma
(NF111 Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot be on other anti-tumor or experimental therapies, and you should not be on high doses of steroids or immunosuppressive therapy.
What data supports the effectiveness of the treatment Poly ICLC for low-grade glioma?
Research shows that Poly ICLC, when used with other treatments, can boost the immune system's response against brain tumors like glioblastoma, which is a more aggressive type of brain cancer. This suggests it might help in treating low-grade glioma by enhancing the body's ability to fight the tumor.12345
Is Poly-ICLC safe for humans?
How is the drug Poly-ICLC unique for treating low-grade glioma?
What is the purpose of this trial?
This trial is testing a medication called Poly-ICLC that boosts the immune system in children with NF1 who have brain tumors that don't respond to usual treatments. The goal is to see if this medication can help shrink or control the tumors by enhancing the body's natural defenses.
Research Team
Juliette Southworth, BS, CCRP
Principal Investigator
University of Alabama at Birmingham, NFCTC
Eligibility Criteria
This trial is for pediatric patients under 22 years with Neurofibromatosis type 1 (NF1) and progressive low-grade gliomas. They must have had previous treatment, measurable tumor growth, and be in stable condition without recent surgeries or radiation therapy. Patients can't join if they've had certain other cancers, are pregnant/breastfeeding, on immunosuppressants, or unable to follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive poly-ICLC 20 mcg/kg/dose twice weekly for progressive low-grade gliomas
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression free survival and toxicity
Treatment Details
Interventions
- Poly ICLC
Poly ICLC is already approved in United States for the following indications:
- Adjuvant therapy for certain cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Children's Healthcare of Atlanta
Collaborator
Children's Hospital Los Angeles
Collaborator