INTRAOSSEOUS ADMINISTRATION OF CHEMOTHERAPY -- OSTEOPORT

DIFFICULTY IN OBTAINING AND MAINTAINING INTRAVENOUS (I.V.) ACCESS FOR MEDICATION ADMINISTRATION IS A FREQUENT COMPLICATION ENCOUNTERED IN PATIENTS UNDERGOING CANCER CHEMOTHERAPY. IN THESE PATIENTS, POOR VENOUS ACCESS OR COMPLICATIONS RELATED TO INDWELLING VENOUS CATHETERS CAN LIMIT THE ADMINISTRATION OF LIFE-SAVING MEDICATIONS. THE OSTEOPORT IS A DEVICE DESIGNED FOR IMPLANTATION INTO THE BONE MARROW, FOR THE PURPOSE OF ADMINISTERING MEDICATIONS THAT TYPICALLY MUST BE GIVEN INTRAVENOUSLY. THIS RESEARCH WILL EVALUATE I.O. ADMINISTRATION OF THE ANTINEOPLASTIC AGENT DOXORUBICIN (DOX) THROUGH THE OSTEOPORT, IN AN ANIMAL (GOAT) MODEL. THE PHARMACOKINETICS OF DOX WILL BE COMPARED BETWEEN I.V. AND I.O. ADMINISTRATION BY MEASURING SERIAL PLASMA LEVELS OF DOX AFTER SINGLE I.V. AND I.O. DOSES, AND AFTER REPEATED I.O. DOSING. SIMILAR BIOAVAILABILITY OF DOX BY BOTH ROUTES OF ADMINISTRATION WILL HELP DEMONSTRATE THE SUITABILITY OF THE OSTEOPORT FOR ADMINISTRATION OF CANCER CHEMOTHERAPY. AT THE CONCLUSION OF THE STUDY, TISSUE SAMPLES WILL BE OBTAINED FROM THE OSTEOPORT IMPLANT SITE FOR HISTOLOGIC EVALUATION, TO DETERMINE IF LOCAL PATHOLOGY IS ASSOCIATED WITH REPEATED I.O. ADMINISTRATION OF DOX.