A pilot trial of GM-CSF and MDX-H210 in patients with erbB-2-positive advanced malignancies

Journal of Immunotherapy

Volumn 22, Issue 4, 1999, Pages 371-379

  Posey, James A ^a   Raspet, Regina ^a   Verma, Udit ^a   Deo, Yashwant M ^a   Keller, Tibor ^b   Marshall, John L ^a   Hodgson, Jennifer ^a   Mazumder, Amitabha ^a   Hawkins, Michael J ^a  

^a GEORGETOWN UNIVERSITY   (United States)

^b MEDAREX INC   (United States)

Author keywords

Antibody fragments; Antibody dependent cytotoxicity; Bispecific antibody; Fc (fragment, crystalline) receptor; HER 2 neu

Indexed keywords

BISPECIFIC ANTIBODY; CYTOKINE; GRANULOCYTE COLONY STIMULATING FACTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; IMMUNOGLOBULIN F(AB')2 FRAGMENT; INTERLEUKIN 6; MDX H 210; MONOCLONAL ANTIBODY; ONCOPROTEIN; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CYTOTOXICITY; DOSE RESPONSE; EFFECTOR CELL; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; GRANULOCYTE; HUMAN; HYPOTENSION; INTRAVENOUS DRUG ADMINISTRATION; MALE; MONOCYTE; ONCOGENE NEU; PILOT STUDY; PRIORITY JOURNAL; RIGOR; SUBCUTANEOUS DRUG ADMINISTRATION;

ADENOCARCINOMA; ADOLESCENT; ADULT; AGED; ANTIBODIES, BISPECIFIC; ANTIBODIES, MONOCLONAL; ANTIBODY FORMATION; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYTOKINES; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; INJECTIONS, SUBCUTANEOUS; LEUKOCYTE COUNT; MALE; MIDDLE AGED; PILOT PROJECTS; RECEPTOR, ERBB-2; SEVERITY OF ILLNESS INDEX; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 0032995774     PISSN: 15249557     EISSN: 15374513     Source Type: Journal    
DOI: 10.1097/00002371-199907000-00011     Document Type: Article

References (19)

1. Akiyama T, Sudo C, Ogawara H, Toyoshima K, Yamamoto T. The product of the human c-erbB-2 gene: a 185 kilodalton glycoprotein with tyrosine kinase activity. Science 1986;232:1644-6.
2. Schechter ALM, Stem DF, Vaidyanathan L, Decker SJ, Drebin JA, Greene MI, Weinberg RA. The neu oncogene: an erbB-related gene encoding a 185,000-Mt tumor antigen. Nature 1984;312:513-16.
3. Semba K, Nomura N, Miyajima N, Saiyo T, Toyoshima K. Similarity of the protein encoded by human c-erbB-2 gene to epidermal growth factor receptor. Nature 1986;319:230-4.
4. Gullick WJ, Berger MS, Bennett PL, Rothbard JB, Waterfield MD. Expression of the c-erbB-2 protein in normal and transformed cells. Int J Cancer 1987;40:246-54.
5. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ulrich A, Mcguire WL. Human breast cancer: correlation of relapse and survival with amplification of the Her-2/neu oncogene. Science 1987;235:177-82.
6. Schhonborn I, Zschiesche W, Spitzer E, Minguillon C, Mohner M, Ebeling K, Grosse R. C-erbB-2 overexpression in primary breast cancer: independent prognostic factor in patients at high risk. Breast Can Res Treat 1994;29:287-95.
7. Press MF, Pike MC, Hung G, et al. Amplification and overexpression of her-2/neu in carcinomas of the salivary gland: correlation with poor prognosis. Cancer Res 1994;54:5675-82.
8. Saffari B, Jones L, El-Naggar A, Felix JC, George J, Press MF. Amplification and overexpression of her-2/neu (c-erbB-2) in endometrial cancers: correlation with overall survival. Cancer Res 1995;55:5693-8.
9. Deo Y, Graziano R, Repp R, Vande Winkel J. Clinical significance of IgG Fc receptors and FcγR-directed immunotherapies. Immunol Today 1997;18:127-35.
10. Backman KA, Guyre PM. Gamma-interferon inhibits Fc receptor II-mediated phagacytosis of tumor cells by human macrophages. Cancer Res 1994;54:2456-61.
11. Valone FH, Kaufman PA, Guyre PM, et al. Phase Ia/Ib trial of bispecific antibody MDX-210 in patients with advanced breast or ovarian cancer that overexpresses the protooncogene her-2/neu. J Clin Oncol 1995;13:2281-92.
12. Kleinerman ES, Knowles RD, Lachchman LB, Gutterman JU. Effect of recombinant granulocyte/macrophage colony-stimulating factor on human monocyte activity in vitro and following intravenous administration. Cancer Res 1988;48:2604-9.
13. Charak BS, Agah R, Mazumder A. Granulocyte-macrophage colony-stimulating factor induced antibody-dependent cellular cytotoxicity in bone marrow macrophages: application in bone marrow transplantation. Blood 1993;81:3474-9.
14. Singleton TP, Niehans GA, Gu F, Litz CE, Hagen K, Qiu Q, Kiang DT, Strickler JG. Detection of c-erbB-2 activation in paraffin-embedded tissue by immnuohistochemistry. Hum Pathol 1992;23:1141-50.
15. Keller T, Graziano A, Mandeil A, Wallace P, Fisher J, Guyre P, Fanger M, Deo Y. Bispecific antibody-dependent cellular cytotoxicity of her2/neu overexpressing tumor cells by Fc receptor type I expressing effector cells. Cancer Res 1997;57:4008-14.
16. Verma UN, Bagg A, Brown E, Mazumder A. Interleukin-2 activation of human bone marrow in long-term cultures: an effective strategy for purging and generation of anti-tumor cytotoxic effectors. BMT 1994;13:115-23.
17. Weiner LM, Clark JI, Davey M, Li WS, Garcia de Palazzo I, Ring DB, Alpaugh RK. Phase I trial of 2B1, a bispecific monoclonal antibody targeting c-erbB-2 and Fc-yRHI. Cancer Res 1995;55:4586-93.
18. Repp R, Valerius T, Wieland G, et al. G-CSF-stimulated pmn in immunotherapy of breast cancer with a bispecific antibody to Fc RI and to her-2/neu (MDX-210). J Hematother 1995;4:415-21.
19. Zujewski J, Hakim F, McAtee N, et al. Phase I trial of bispecific antibody MDX-H210 in patients with erbB-2 positive tumors [Abstr. 1389], ProcASCO 1996;15:445.