title: Immunotherapy of pancreatic cancer with monoclonal antibody BW 494.
abstract: In a phase I trial 34 patients with pancreatic cancer were treated with the murine monoclonal antibody (MAb) BW 494 (BI 51.011) directed against a glycoprotein antigen. The patients received repeated doses of MAb over a time period from 5 to 14 days (highest single dose 100 mg, highest cumulative dose 490 mg). During this treatment serum levels of murine IgG increased to 43.4 micrograms/ml. The serum half life of murine IgG ranged from 2 to 3 days. Repeated injections of MAb BW 494 were normally well-tolerated when given within the first 15 days. Two patients presented with fatigue and a neuritis-like syndrome 2 weeks after the last IgG infusion which had resolved spontaneously by the next day. Severe allergic reactions were observed in 3 patients after repeated injections of the MAb. These 3 patients had high levels of human anti-murine antibodies (HAMA). Four weeks after the first application of MAb BW 494, 17/18 patients presented with HAMA (IgG). It could be demonstrated that the anti-murine response was in part anti-idiotypic. At the moment 16/34 patients are eligible for evaluation of tumor response. There was no complete or partial remission; however, 2 patients responded with minor tumor regression up to 32 weeks documented by reduction of liver metastases and primary tumor in CAT scan. Five additional patients presented with a long period of stable disease after immunotherapy (up to 40 weeks). Nine patients had progressive tumor disease in spite of MAb treatment.
authors.affiliation: Research Department of Behringwerke, Marburg/Lahn, FRG.
authors.forename: G
authors.initials: G
authors.lastname: Schulz
authors.forename: M
authors.initials: M
authors.lastname: Büchler
authors.forename: K H
authors.initials: KH
authors.lastname: Muhrer
authors.forename: R
authors.initials: R
authors.lastname: Klapdor
authors.forename: R
authors.initials: R
authors.lastname: Kübel
authors.forename: H P
authors.initials: HP
authors.lastname: Harthus
authors.forename: N
authors.initials: N
authors.lastname: Madry
authors.forename: K
authors.initials: K
authors.lastname: Bosslet
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D000906:Antibodies / Q000032:analysis; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000920:Antibody-Dependent Cell Cytotoxicity; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis; D007167:Immunotherapy; D008297:Male; D051379:Mice; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000276:immunology / Q000628:therapy*
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D007074:Immunoglobulin G