SEVERAL RECENT REPORTS SUGGEST THAT EXTRACORPOREAL PERFUSION OF TUMOR BEARING PLASMA OVER PROTEIN A CONTAINING SUBSTRATES CAN RESULT IN OBJECTIVE TUMOR REGRESSION IN THE HOST.

SEVERAL RECENT REPORTS SUGGEST THAT EXTRACORPOREAL PERFUSION OF TUMOR BEARING PLASMA OVER PROTEIN A CONTAINING SUBSTRATES CAN RESULT IN OBJECTIVE TUMOR REGRESSION IN THE HOST. IN THE PRESENT INVESTIGATION, PURIFIED STAPHYLOCOCCAL PROTEIN A IS ISOLATED, COUPLED TO AN INERT BIOCOMPATIBLE SILICA SUBSTRATE, HOUSED IN A DISPOSABLE CARTRIDGE, STERILIZED AND USED TO TREAT MALIGNANCY. A SIMILAR SYSTEM HAS BEEN UTILIZED BY INVESTIGATORS AND RESULTED IN OBJECTIVE TUMOR REGRESSIONS IN PATIENTS WITH BREAST ADENOCARCINOMA (BENSINGER ET AL., NEW ENG. J. MED. 306: 935, 1982). PATIENTS TO BE STUDIED IN THIS RESEARCH GRANT PROPOSAL WILL HAVE STAGE II BREAST CANCER AND STAGE II MELANOMA. IDEAL PATIENTS WILL HAVE LOCAL SKIN METASTASES OR RECURRENCE THAT CAN BE DIRECTLY OBSERVED FOR ANTI-TUMOR EFFECTS AND CAN BE BIOPSIED. IN THE SIX MONTH PERIOD COVERED BY THIS PROPOSAL, IT IS ESTIMATED THAT 14 PATIENTS COULD BE TREATED AND STUDIED EMPLOYING EXTRACORPOREAL PROTEIN A IMMUNOADSORPTION. THE OBJECTIVES OF THIS STUDY ARE TO COLLECT PATIENT SERA BEFORE AND DURING EXTRACORPOREAL IMMUNOADSORPTION AND TO ANALYZE THE SERA FOR QUANTITATIVE CHANGES IN IMMUNOGLOBULIN LEVELS, TOTAL HEMOLYTIC COMPLEMENT LEVELS, CIRCULATING IMMUNE COMPLEXES, AND TUMOR IMMUNITY (WHEN APPROPRIATE). THESE IMMUNOLOGIC PARAMETERS WILL BE ASSESSED IN ASSOCIATION WITH PHYSICAL EXAMINATIONS, MEASUREMENT OF OBJECTIVE TUMOR (WHEN APPROPRIATE), AND X-RAYS OF AREAS OF TUMOR INVOLVEMENT. IN ADDITION, PROTEIN(S) BOUND TO THE PROTEIN A IMMUNOADSORPTION WILL BE ANALYZED FOR THE PRESENCE OF IMMUNOGLOBULIN, COMPLEMENT COMPONENTS, AND IMMUNE COMPLEXES. THESE ANALYSES WILL ENABLE US TO DETERMINE IF THERE IS A MODIFICATION IN THE BIOLOGIC RESPONSE AS A RESULT OF EXTRACORPOREAL PROTEIN A IMMUNOADSORPTION WHICH IS ASSOCIATED WITH CLINICAL IMPROVEMENT AND WILL ASSIST IN THE DEVELOPMENT OF A SAFE COMMERCIALLY AVAILABLE TREATMENT DEVICE. THIS IS A STUDY TO EVALUATE THE TUMOR BEARING PATIENT BEFORE AND AFTER EXTRACORPOREAL TREATMENT IN A BASIC RESEARCH PHASE I PROPOSAL WITH SPECIFIC AIMS DIRECTED TOWARD THE DEVELOPMENT OF A SAFE AND EFFICACIOUS TREATMENT UNIT AND PRELIMINARY ELUCIDATION OF POSSIBLE MODE(S) OF ACTION.