title: A novel polymer gel for the delivery of local therapies to intracranial tumors: In vivo safety evaluation.
abstract: The treatment of intracranial malignancies is limited by the ability of systemically administered therapies to cross the blood-brain barrier. Royer resorbable matrix, or R-Gel, is a dextran polymer administered in liquid form via needle injection. Within minutes of preparation, the polymer forms a gel and subsequently solidifies, thereby conforming to the dimensions of the injection cavity. R-Gel can accommodate a wide variety of therapeutic agents that may provide new options for local treatment delivery. This preclinical study evaluates the neurotoxicity of R-Gel implanted in the rat brain. Fifteen rats underwent intracranial administration of R-Gel (N = 9) or saline (N = 6) were monitored for systemic and neurotoxicity, and sacrificed at pre-determined time points. Animals that received the R-Gel injection demonstrated no behavioral changes or weight loss. Histopathologic analysis revealed an inflammatory response in both groups on day 3 and day 7 after implantation, which resolved by day 42. These results suggest that intracranial R-Gel is well tolerated. Therapeutic studies of chemotherapy-complexed R-Gel are underway.
authors: Division of Hematology-Oncology, Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA. david.gerber@utsouthwestern.edu
authors: David E
authors: DE
authors: Gerber
authors: Gary L
authors: GL
authors: Gallia
authors: Betty M
authors: BM
authors: Tyler
authors: Charles G
authors: CG
authors: Eberhart
authors: Gar
authors: G
authors: Royer
authors: Stuart A
authors: SA
authors: Grossman
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016503:Drug Delivery Systems; D005069:Evaluation Studies as Topic; D005260:Female; D005782:Gels / Q000009:adverse effects* / Q000138:chemical synthesis / Q000737:chemistry; D008422:Materials Testing; D011108:Polymers / Q000009:adverse effects* / Q000138:chemical synthesis / Q000737:chemistry; D051381:Rats; D011916:Rats, Inbred F344
chemical_list: D000970:Antineoplastic Agents; D005782:Gels; D011108:Polymers