LGG-58. A PHASE II TRIAL OF POLY-ICLC IN THE MANAGEMENT OF RECURRENT OR PROGRESSIVE PEDIATRIC LOW GRADE GLIOMAS (NCT01188096): PRELIMINARY ANALYSIS

Abstract

Low dose Poly‐ICLC (Polyinosinic‐Polycytidylic acid stabilized with polylysine and carboxymethylcellulose) has a direct immune enhancing action independent of interferon, including increased antibody response to antigen, and NK cell, T‐cell, macrophage and cytokine activation. METHODS: We conducted an immunotherapy trial to evaluate the effect of Poly‐ICLC in the children with recurrent or progressive low grade gliomas. Criteria for enrollment: progression by MRI and or visual deterioration. Patients received Poly‐ICLC 20mcg/kg/dose IM injection twice a week for up to 24 months. RESULTS: 23 patients enrolled, 22 evaluable. Ages 2‐20 years. Ten females and 13 males Location: suprasellar (11), spine (1), disseminated (4), others (7). Six patients with NF‐1. Pathology: JPA (11), pilomyxoid (5), no pathology (3), Diffuse Astrocytoma, ganglioglioma, Glioneuronal tumor, LGG NOS (1 each). Followup range 3 to 58 months. Responses: 43% stable disease, 17% (4/23) partial responses‐3 with NF‐1. Visual fields and acuity improved in 33% of patients with NF‐1. Two JPA patients that have completed 24 months of therapy: one non‐NF with SD and PFS 58 months, one NF‐1, PR, PFS for 28 months. Most common toxicities included: fevers, discomfort at the injection site, Grade 1 neutropenia, lymphocytopenia, hypophosphatemia, ALT elevation. One case of grade 4 intratumoral hemorrhage, required medical management alone. No patient required transfusion or admission for fever and neutropenia. No reports of neuropathy. CONCLUSION: Poly‐ICLC is well tolerated, minimal toxicity, radiographic and clinical responses were demonstrated in patients with LGG. Larger clinical trials with Poly‐ICLC are being designed.