A phase I study of bolus versus continuous infusion of the anti-CD19 immunotoxin, IgG-HD37-dgA, in patients with B-cell lymphoma

Blood

Volumn 88, Issue 4, 1996, Pages 1188-1197

  Stone, Marvin J ^b   Sausville, Edward A ^b   Fay, Joseph W ^b   Headlee, Donna ^b   Collins, Robert H ^b   Figg, William D ^b   Stetler Stevenson, Maryalice ^b   Jain, Vinay ^b   Jaffe, Elaine S ^b   Solomon, Diane ^b   Lush, Richard M ^b   Senderowicz, Adrian ^b   Ghetie, Victor ^b   Schindler, John ^b   Uhr, Jonathan W ^b   Vitetta, Ellen S ^a  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

IGG HD37 DGA; IMMUNOTOXIN; MONOCLONAL ANTIBODY B 43; RICIN A; UNCLASSIFIED DRUG;

ACROCYANOSIS; ARTICLE; B CELL LYMPHOMA; BLEEDING; CLINICAL ARTICLE; CONTINUOUS INFUSION; DISULFIDE BOND; DRUG CONJUGATION; DRUG SAFETY; HUMAN; HUMAN CELL; HUMAN TISSUE; IMMUNOTOXICITY; INTRAVENOUS DRUG ADMINISTRATION; MAXIMUM ALLOWABLE CONCENTRATION; PRIORITY JOURNAL; RHABDOMYOLYSIS; VASCULITIS;

EID: 9444268741     PISSN: 00064971     EISSN: None     Source Type: Journal    
DOI: 10.1182/blood.v88.4.1188.bloodjournal8841188     Document Type: Article

References (36)

1. Vitetta ES, Thorpe PE: Antibodies in cancer therapy: Basic principals of monoclonal antibodies. Section 21.2: Immunotoxins, in Devita V, Hellman S, Rosenberg S (eds): Biologic Therapy of Cancer. Philadelphia, PA, Lippincott, 1991, p 482
2. Pastan I, FitzGerald D: Pseudomonas exotoxin: Chimeric toxins. J Biol Chem 264:15157, 1989
3. Dorken B, Schwarz E, Feller AC, Hammerling G, Hunstein W: Production of monoclonal antibodies for the diagnosis of minimal infiltration of leukemic cells into the bone marrow. Verh Dtsch Ges Pathol 67:65, 1983
4. Nadler LM: B cell/leukemia panel workshop: Summary and comments, in Reinherz EL, Haynes BF, Nadler LM, Bernstein ID (eds): Leukocyte Typing II. New York, NY, Springer-Verlag, 1986, P 3
5. Pezzutto A, Dörken B, Moldenhauer G, Rabinovitch PS, Clark EA: in McMichael AJ (ed): Leukocyte Typing III. Oxford, UK, Oxford, 1987
6. Engert A, Martin G, Amlot P, Wijdenes J, Diehl V, Thorpe P: Immunotoxins constructed with anti-CD25 monoclonal antibodies and deglycosylated ricin A-chain have potent anti-tumour effects against human Hodgkin cells in vitro and solid Hodgkin tumours in mice. Int J Cancer 49:450, 1991
7. Faure GC, Bene MC, Bolle-Chanal MH: Expression of CD25 (Tac antigen) in lymphoid leukemias and non-Hodgkin lymphomas. Eur J Immunol 38:26, 1987
8. Pasqualucci L, Wasik M, Teicher BA, Flenghi L, Bolognesi A, Stirpe F, Polito L, Falini B, Kadin ME: Antitumor activity of anti-CD30 immunotoxin (ber-h2 saporin) in vitro and in severe combined immunodeficiency disease mice xenografted with human CD30(+) anaplastic large-cell lymphoma. Blood 85:2139, 1995
9. Vitetta ES, Thorpe PE, Uhr JW: Immunotoxins: Magic bullets or misguided missiles. Immunol Today 14:252, 1993
10. Uckun FM: Immunotoxins for the treatment of leukemia. Br J Haematol 85:435, 1993
11. Uckun FM, Finnegan D, Gunther R, Majerus C, Park CH, Irvin JD, Kuebelbeck V, Myers DE, Chelstrom LC: In vivo efficacy of B-43 (anti-CD 19)-pokeweed antiviral protein (PAP) immunotoxin against BCL-1 murine B-cell leukemia. Blood 79:2201, 1992
12. Uckun FM, Chelstrom LM, Irvin JD, Finnegan D, Gunther R, Young J, Kuebelbeck V, Myers D, Houston L: In vivo efficacy of B43 (anti-CD 19)-pokeweed antiviral protein immunotoxin against BCL-1 murine B-cell leukemia. Blood 79:2649, 1992
13. Foss F, Borkowski T, Gilliom M, Stetler-Stevenson M, Jaffe E, Tomkins A, Bastian A, Nylen P, Woodworth T, Udey M, Sausville EA: Chimeric fusion protein toxin DAB (486) IL2 in refractory mycosis fungoides and the sezary syndrome: Correlation of activity and IL2 receptor expression in a phase II study. Blood 84:1765, 1994
14. LeMaistre CF, Meneghetti C, Rosenblum M, Reuben J, Parker K, Shaw J, Deisseroth A, Woodworth T, Parkinson DR: Phase-I trial of an interleukin-2 (IL-2) fusion toxin (DAB486IL-2) in hematologic malignancies expressing the IL-2 receptor. Blood 79:2547, 1992
15. Ghetie V, Vitetta ES: Immunotoxins in the therapy of cancer: From bench to clinic. Pharmacol Ther 63:209, 1994
16. Grossbard ML, Freedman AS, Ritz J, Coral F, Goldmacher VS, Eliseo L, Spector N, Dear K, Lambert JM, Blattler WA, Taylor JA, Nadler LM: Serotherapy of B-cell neoplasms with anti-B4-blocked ricin - A phase-I trial of daily bolus infusion. Blood 79:576, 1992
17. Goldmacher VS, Scott CF, Lambert JM, McIntyre GD, Blattler WA, Collnhson AR, Stewart JK, Chong LD, Cook S, Slayter HS: Cytotoxicity of gelonin and its conjugates with antibodies is determined by the extent of their endocytosis. J Cell Physiol 141:222, 1989
18. Grossbard ML, Lambert JM, Goldmacher VS, Spector NL, Kinsella J, Eliseo L, Coral F, Taylor JA, Blattler WA, Epstein CL, Nadler LM: Anti-b4-blocked ricin - A phase-I trial of 7-day continuous infusion in patients with B-cell neoplasms. J Clin Oncol 11:726, 1993
19. Lambert JM, McIntyre G, Gauthier MN, Zullo D, Rao V, Steeves RM, Goldmacher VS, Blattler WA: The galactose-binding sites of the cytotoxic lectin ricin can be chemically blocked in high yield with reactive ligands prepared by chemical modification of glycopeptides containing triantennary N-linked oligosaccharides. Biochemistry 30:3234, 1991
20. Blakey DC, Skilleter DN, Price RJ, Thorpe PE: Uptake of native and deglycosylated ricin A-chain immunotoxins by mouse liver parenchymal and non-parenchymal cells in vitro and in vivo. Biochim Biophys Acta 968:172, 1988
21. Blakey DC, Watson GJ, Knowles PP, Thorpe PE: Effect of chemical deglycosylation of ricin A chain on the in vivo fate and cytotoxic activity of an immunotoxin composed of ricin A chain and anti-Thy 1.1 antibody. Cancer Res 47:947, 1987
22. Thorpe PE, Wallace PM, Knowles PP, Relf MG, Brown ANF, Watson GJ, Blakey DC, Newell DR: Improved anti-tumor effects of immunotoxins prepared with deglycosylated ricin A chain and hindered disulfide linkages. Cancer Res 48:6396, 1988
23. Thorpe PE, Detre SI, Foxwell BMJ, Brown ANF, Skilleter DN, Wilson G, Forrester JA, Stirpe F: Modification of the carbohydrate in ricin with metaperiodate-cyanoborohydride mixtures. Effects on toxicity and in vivo distribution. Eur J Biochem 147:197, 1985
24. Ghetie V, Ghetie M, Uhr JW, Vitetta ES: Large scale preparation of immunotoxins constructed with the Fab' fragment of IgG1 murine monoclonal antibodies and chemically deglycosylated ricin A chain. J Immunol Methods 112:267, 1988
25. Amlot PL, Stone MJ, Cunningham D, Fay J, Newman J, Collins R, May R, McCarthy M, Richardson J, Ghetie V, Ramilo O, Thorpe PE, Uhr JW, Vitetta ES: A phase I study of an anti-CD22-deglycosylated ricin A chain immunotoxin in the treatment of B-cell lymphomas resistant to conventional therapy. Blood 82:2624, 1993
26. Sausville EA, Headlee D, Stetler-Stevenson M, Jaffe ES, Solomon D, Figg WD, Herdt J, Kopp WC, Rager H, Steinberg SM, Ghetie V, Uhr J, Wittes RE, Vitetta ES: Continuous infusion of the anti-CD22 immunotoxin, IgG-RFB4-SMPT-dgA in patients with B cell lymphoma: A phase I study. Blood 85:3457, 1995
27. Vitetta ES, Stone M, Amlot P, Fay J, May R, Till M, Newman J, Clark P, Collins R, Cunningham D, Ghetie V, Uhr JW, Thorpe PE: A phase I immunotoxin trial in patients with B cell lymphoma. Cancer Res 51:4052, 1991
28. Anderson KC, Bates MP, Slaughenhoupt BL, Pinkus GS, Schlossman SF, Nadler LM: Expression of human B cell-associated antigens on leukemias and lymphomas: A model of human B cell differentiation. Blood 63:1424, 1984
29. Ghetie M, Tucker K, Richardson J, Uhr JW, Vitetta ES: The anti-tumor activity of an anti-CD22-immunotoxin in SCID mice with disseminated Daudi lymphoma is enhanced by either an anti-CD19 antibody or an anti-CD19 immunotoxin. Blood 80:2315, 1992
30. Ghetie MA, Podar EM, Gordon BE, Pantazis P, Uhr JW, Vitetta ES: Combination immunotoxin treatment and chemotherapy in SCID mice with advanced, disseminated Daudi lymphoma. Int J Cancer (in press)
31. Ghetie V, Thorpe PE, Ghetie M, Knowles P, Uhr JW, Vitetta ES: The GLP large scale preparation of immunotoxins containing deglycosylated ricin A chain and a hindered disulfide bond. J Immunol Methods 142:223, 1991
32. Dorken B, Moldenhauer G, Schwartz R, Pezzutto A, Hammerling G: B cell differentiation antigens identified by monoclonal antibodies (HD6, HD28, HD37, HD39). Immunobiology 165:253, 1983
33. Yamaoka K, Nakagawa J, Uno T: Application of Akaike's Information Criterion (AK) in the evaluation of linear pharmacokinetic equations. J Pharmacokinet Biopharm 2:165, 1978
34. Conry RM, Khazaeli MB, Saleh MN, Vitetta ES, Liu T, Lobuglio AF: Phase I trial of an anti-CD19 deglycosylated ricin A chain immunotoxin in non-Hodgkin's lymphoma: Effect of an intensive schedule of administration. J Immunother 18:231, 1996
35. Soler-Rodriguez AM, Ghetie MA, Oppenheimer-Marks N, Uhr JW, Vitetta ES: Ricin A-chain and ricin A-chain immunotoxins rapidly damage human endothelial cells: Implications for vascular leak syndrome. Exp Cell Res 206:227, 1993
36. Baluna R, Ghetie V, Oppenheimer-Marks N, Vitetta ES: The binding of ricin A-chain to fibronectin; possible implications for vascular leak syndrome in immunotoxin-treated patients. Int J Immunopharm (in press)