ABSTRACT: 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). Follow-up 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.
