A phase I trial of the single-chain immunotoxin SGN-10 (BR96 sFv-PE40) in patients with advanced solid tumors

Clinical Cancer Research

Volumn 8, Issue 10, 2002, Pages 3092-3099

  Posey, James A ^a   Khazaeli, Mohammad B ^a   Bookman, Michael A ^c   Nowrouzi, Anahit ^a   Grizzle, William E ^b   Thornton, Jennifer ^a   Carey, Delicia E ^a   Lorenz, Jennifer M ^d   Sing, Amy P ^d   Siegall, Clay B ^d   LoBuglio, Albert F ^a   Saleh, Mansoor N ^a  

^a University of Alabama at Birmingham   (United States)

^b University of Alabama at Birmingham   (United States)

^c FOX CHASE CANCER CENTER   (United States)

^d SEATTLE GENETICS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOHYDRATE ANTIGEN; IMMUNOTOXIN; MONOCLONAL ANTIBODY; PSEUDOMONAS EXOTOXIN; SGN 10;

ADULT; ADVANCED CANCER; AGED; ANTIGEN DETECTION; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; MALE; MAXIMUM TOLERATED DOSE; PRIORITY JOURNAL; SOLID TUMOR;

ADULT; AGED; ANTIBODIES, MONOCLONAL; COHORT STUDIES; FEMALE; HUMANS; IMMUNOTOXINS; LEWIS BLOOD-GROUP SYSTEM; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; RECOMBINANT FUSION PROTEINS; TREATMENT OUTCOME;

EID: 0036793823     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

1. Grillo-Lopez, A. J. Rituximab: an insider's historical perspective. Semin. Oncol., 27: 9-16, 2000.
2. Slamon, D., and Pegram, M. Rationale for trastuzumab (Herceptin) in adjuvant breast cancer trials. Semin. Oncol., 28: 13-19, 2001.
3. Matthey, B., Engert, A., and Barth, S. Recombinant immunotoxins for the treatment of Hodgkin's disease. Int. J. Mol. Med., 5: 509-514, 2000.
4. Schindler J., Sausville, E., Messmann, R., Uhr, J. W., and Vitetta, E. S. The toxicity of deglycosylated ricin A chain-containing immunotoxins in patients with non-Hodgkin's lymphoma is exacerbated by prior radiotherapy: a retrospective analysis of patients in five clinical trials. Clin. Cancer Res., 7: 255-258, 2001.
5. Kreitman, R. J., Wilson, W. H., Bergeron, K., Raggio, M., Stetler-Stevenson, M., FitzGerald, D. J., and Pastan, I. Efficacy of the anti-CD22 recombinant immunotoxin BL22 in chemotherapy-resistant hairy-cell leukemia. N. Eng. J. Med., 345: 241-247, 2001.
6. Kreitman, R. J. Chimeric fusion proteins-Pseudomonas exotoxin-based. Curr. Opin. Invest. Drugs, 2: 1282-1293, 2001.
7. Friedman, P. N., McAndrew, S. J., Gawlak, S. L., Chace, D., Trail, P. A., Brown, J. P., and Siegall, C. B. BR96 sFv-PE40, a potent single chain immunotoxin that selectively kills carcinoma cells. Cancer Res., 53: 334-339, 1993.
8. Siegall, C. B., Chace, D., Mixan, B., Garrigues, U., Wan, H., Paul, L., Wolff, E., Hellstrom, I., and Hellstrom, K. E. In vitro and in vivo characterization of BR96 sFv-PE40. A single chain immunotoxin fusion protein that cures human breast carcinoma xenografts in athymic mice and rats. J. Immunol., 152: 2377-2384, 1994.
9. y)-related cell surface antigens. Cancer Res., 50: 2183-2190, 1990.
10. Conry, R. M., Khazaeli, M. B., Saleh, M. N., Ghetie, V., Vitetta, E. S., Liu, T., and LoBuglio. A. F. 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. Emphas. Tumor Immunol., 18: 231-241, 1995.
11. Pai, L. H., Wittes, R., Setser, A., Willingham, M. D., and Pastan, I. Treatment of advanced solid tumors with immunotoxin LMB-1: an antibody linked to Pseudomonas exotoxin. Nat. Med., 2: 350-353, 1996.
12. Siegall, C. B., Liggitt, D., Chace, D., Tepper, M. A., and Fell, H. P. Prevention of immunotoxin-mediated vascular leak syndrome in rats with retention of antitumor activity. Proc. Natl. Acad. Sci. USA, 91: 9514-9518, 1994.
13. Siegall, C. B., Liggitt, D., Chace, D., Mixan, B., Sugai, J., Davidson, T., and Steinitz, M. Characterization of vascular leak syndrome induced by the toxin component of Pseudomonas exotoxin-based immunotoxins and its potential inhibition with nonsteroidal anti-inflammatory drugs. Clin. Cancer Res., 3: 339-345, 1997.
14. Kuan, C. T., Pai, L. H., and Pastan, I. Immunotoxins containing Pseudomonas exotoxin that target Ley damage human endothelial cells in an antibody-specific mode: relevance to vascular leak syndrome. Clin. Cancer Res., 1: 1589-1594, 1995.
15. Baluna, R., Rizo, J., Gordon, B. E., Ghetie, V., and Vitetta, E. S. Evidence for a structural motif in toxins and interleukin-2 that may be responsible for binding to endothelial cells and initiating vascular leak syndrome. Proc. Natl. Acad. Sci. USA, 96: 3957-3962, 1999.
16. Friedman, P. N. Chace, D. F., Trail, P. A., and Siegall, C. B. Antitumor activity of the single chain immunotoxin BR96 sFv-PE40 against established breast and lung tumor xenografts. J. Immunol., 150: 3054-3061, 1993.
17. y) antigen. Semin. Cancer Biol., 6: 289-295, 1995.
18. Haggerty, H. G., Warner, W. A., Comereski, C. R., Peden, W. M., Mezza, L. E., Damle, B. D., Siegall, C. B., and Davidson, T. J. BR96 sFv-PE40 immunotoxin: non clinical safety assessment. Toxicol. Pathol., 27: 97-94, 1999.
19. Myers, R. B., Srivastava, S., and Grizzle, W. E. Lewis Y antigen as detected by the monoclonal antibody BR96 is expressed strongly in prostatic adenocarcinoma. J. Urol., 153: 1572-1574, 1995.
20. Grizzle, W. E., Myers, R. B. Manne, U., Stockard, C. R., Harkins, L. E., and Srivastava, S. Factors affecting immunohistochemical evaluation of biomarker expression in neoplasia. In: M. Hanausek and Z. Walaszek (eds.), John Walker's Methods in Molecular Medicine, pp. 161-179. Totowa, NJ: Humana Press, Inc., 1998.
21. Grizzle, W. E., Myers, R. B., Manne, U., and Srivastava, S. Immunohistochemical evaluation of biomarkers in prostatic and colorectal neoplasia. In: M. Hanausek and Z. Walaszek (eds.), John Walker's Methods in Molecular Medicine-Tumor Marker Protocols, pp. 143-150. Totowa, NJ: Humana Press, Inc., 1998.
22. Khazaeli, M. B., Conry, R. M., and LoBuglio, A. F. Human immune response to monoclonal antibodies. J. Immunother., 15: 42-52, 1994.
23. 131I-chimeric mouse/human B72.3 (human γ4) monoclonal antibody in humans. Cancer Res., 41: 5461-5466, 1991.
24. SAS/STAT User's Guide, Version 6, Ed. 4, Vols. 1 and 2. Cary, NC: SAS Institute, Inc., 1989.
25. Y-expressing epithelial tumors. J. Clin. Oncol., 18: 2282-2292, 2000.
26. Pai, L. H., Wittes, R., Setser, A., Pearson, D., Willingham, M. C., and Pastan, I. Phase I trial of recombinant immunotoxin LMB-7 (B3 (Fv) PE38) for adult solid tumors. Proc. Am. Assoc. Cancer Res., 38: 85, 1997.
27. Reiter, Y., Brinkmann, U., Webber, K. O., Jung, S-H., Lee, B., and Pastan, I. Engineering interchain disulfide bonds into conserved framework regions of Fv fragments: improved biochemical characteristics of recombinant immunotoxins containing disulfide-stabilized Fv. Protein Eng., 7: 697-704, 1994.
28. Benhar, I., Reiter, Y., Pal, L. H., and Pastan, I. Administration of disulfide-stabilized Fv-immunotoxins B1 (dsFv)-PE38 and B3 (dsFv)-PE38 by continuous infusion increases their efficacy in curing large tumor xenografts in nude mice. Int. J. Cancer, 62: 351-355, 1995.
29. Kuzel, T. M. DAB(389)IL-2 (denileukin diftitox. ONTAK): review of clinical trials to date. Clin. Lymphoma, 1 (Suppl. 1): S33-S36, 2000.
30. Foss, F. M. DAB(389)IL-2 (ONTAK): a novel fusion toxin therapy for lymphoma. Clin. Lymphoma, 1: 110-116, 2000.
31. Najafian, N., and Sayegh, M. H. CTLA4-Ig: a novel immunosuppressive agent. Expert Opin. Investig. Drugs, 9: 2147-2157, 2000.
32. Kenyon, N. S., Fernandez, L. A., Lehmann, R., Masetti, M., Ranuncoli, A., Chatzipetrou, M., Iaria, G., Han, D., Wagner, J. L., Ruiz, P., Berho, M., Inverardi, L., Alejandro, R., Mintz, D. H., Kirk, A. D., Harlan, D. M., Burkly, L. C., and Ricordi, C. Long-term survival and function of intrahepatic islet allografts in baboons treated with humanized anti-CD154. Diabetes, 48: 1473-1481, 1999.
33. Faurschou, M., Hasselbalch, H. C., and Nielsen, O. J., Sustained remission of platelet counts following monoclonal anti-CD20 antibody therapy in two cases of idiopathic autoimmune thrombocytopenia and neutropenia. Eur. J. Haematol., 66: 408-411, 2001.