A Phase II Trial of Poly-ICLC for Progressive, Previously Treated Low-Grade Gliomas in Children and Young Adults with Neurofibromatosis Type 1

GOALS

To evaluate the efficacy of Poly-ICLC in pediatric NF1 patients with progressive low-grade glioma (LGG) as measured by objective tumor response rate (CR+PR) within the first 48 weeks (12 cycles) of therapy

DRUGS

Poly-ICLC is a synthetic drug that is being studied in the treatment of cancer and for its ability to stimulate the immune system. Previous trials of Poly-ICLC in both adults and children have suggested a possible beneficial effect in adults and children with newly diagnosed or recurrent brain tumors.

ELIGIBILITY

This study is open to participants less than 22 year of age who have Neurofibromatosis Type 1 with low grade glioma (WHO Grade 1 and 2) and have had at least one prior medical treatment for the target low grade glioma. A full list of criteria can be obtained by contacting one of the study sites and/or checking clinicaltrials.gov.

PROTOCOL

Study participants will receive Poly-ICLC administered by intramuscular injection twice weekly for approximately 2 years (24 cycles of therapy). Clinical response is assessed by MRI every 3 months.

PROTOCOL CHAIRS

• Dolly Aguilera, MD (Chair)
• David Wolf, MD (Co-Chair)
• Miriam Bornhorst, MD (Co-Chair)

CURRENT STATUS

The Poly-ICLC study is currently enrolling eligible participants.