A phase II study of a 5T4 oncofoetal antigen tumour-targeted superantigen (ABR-214936) therapy in patients with advanced renal cell carcinoma

British Journal of Cancer

Volumn 96, Issue 4, 2007, Pages 567-574

  Shaw, D M ^a   Connolly, N B ^a   Patel, P M ^b   Kilany, S ^c   Hedlund, G ^c   Nordle, O ^c   Forsberg, G ^c   Zweit, J ^a   Stern, P L ^a   Hawkins, R E ^a  

^a CHRISTIE HOSPITAL   (United Kingdom)

^b ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

^c Active Biotech Research AB   (Sweden)

Author keywords

Motzer; Renal cell carcinoma; Tumour associated antigen; Tumour targeted superantigen

Indexed keywords

ABR 214936; ANTINEOPLASTIC AGENT; INTERLEUKIN 2; STAPHYLOCOCCUS ENTEROTOXIN A; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER CONTROL; CANCER FATIGUE; CANCER PATIENT; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; CYTOKINE PRODUCTION; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG EXPOSURE; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; EXPECTATION; FEMALE; FEVER; FOLLOW UP; HUMAN; HYPERTENSION; HYPOTENSION; KIDNEY CARCINOMA; LETHARGY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; REPEAT PROCEDURE; RIGOR; SURVIVAL RATE; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTIGENS, NEOPLASM; CARCINOMA, RENAL CELL; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG TOXICITY; ENTEROTOXINS; FEMALE; FOLLOW-UP STUDIES; HUMANS; INJECTIONS, INTRAVENOUS; INTERLEUKIN-2; KIDNEY NEOPLASMS; MALE; MEMBRANE GLYCOPROTEINS; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; PROGNOSIS; RECOMBINANT FUSION PROTEINS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 33847205332     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603567     Document Type: Article

References (41)

1. Alpaugh RK, Schultz J, McAleer C, Giantonio BJ, Persson R, Burnite M, Nielsen SE, Vitek L, Persson B, Weiner LM (1998a) Superantigen-targeted therapy: phase I escalating repeat dose trial of the fusion protein PNU-214565 in patients with advanced gastrointestinal malignancies. Clin Cancer Res 4: 1903-1914
2. Alpaugh RK, Weiner LM, Persson R, Persson B (1998b) Overview of clinical trials employing antibody-targeted superantigens. Adv Drug Deliv Rev 31: 143-152
3. Brodin TN, Persson R, Soegaard M, Ohlsson L, d'Argy R, Olsson J, Molander A, Antonsson P, Gunnarsson P, Kalland T, Dohlsten M (1998) Man-made superantigens: tumor-selective agents for T-cell-based therapy. Adv Drug Deliv Rev 31: 131-142
4. Cheng JD, Babb JS, Langer C, Aamdal S, Robert F, Engelhardt LR, Fernberg O, Schiller J, Forsberg G, Alpaugh RK, Weiner LM, Rogatko A (2004) Individualized patient dosing in phase I clinical trials: the role of escalation with overdose control in PNU-214936. J Clin Oncol 22: 602-609
5. Clark PE, Hall MC, Miller A, Ridenhour KP, Stindt D, Lovato JF, Patton SE, Brinkley W, Das S, Torti FM (2004) Phase II trial of combination interferon-alpha and thalidomide as first-line therapy in metastatic renal cell carcinoma. Urology 63: 1061-1065
6. Collaborators MRC (1999) Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Lancet 353: 14-17
7. Dawson NA, Guo C, Zak R, Dorsey B, Smoot J, Wong J, Hussain A (2004) A phase II trial of gefitinib (Iressa, ZD1839) in stage IV and recurrent renal cell carcinoma. Clin Cancer Res 10: 7812-7819
8. de Gramont A, Van Cutsem E (2005) Investigating the potential of bevacizumab in other indications: metastatic renal cell, non-small cell lung, pancreatic and breast cancer. Oncology 69(Suppl 3): 46-56
9. Dermime S, Gilham DE, Shaw DM, Davidson EJ, Meziane el K, Armstrong A, Hawkins RE, Stern PL (2004) Vaccine and antibody-directed T cell tumour immunotherapy. Biochim Biophys Acta 1704: 11-35
10. Dohlsten M, Abrahmsen L, Bjork P, Lando PA, Hedlund G, Forsberg G, Brodin T, Gascoigne NR, Forberg C, Lind P, Kalland T (1994) Monoclonal antibody-superantigen fusion proteins: tumor-specific agents for T-cell-based tumor therapy. Proc Natl Acad Sci USA 91: 8945-8949
11. Dohlsten M, Hansson J, Ohlsson L, Litton M, Kalland T (1995) Antibody-targeted superantigens are potent inducers of tumor-infiltrating T lymphocytes in vivo. Proc Natl Acad Sci USA 92: 9791-9795
12. Dohlsten M, Hedlund G, Akerblom E, Lando PA, Kalland T (1991a) Monoclonal antibody-targeted superantigens: a different class of antitumor agents. Proc Natl Acad Sci USA 88: 9287-9291
13. Dohlsten M, Hedlund G, Kalland T (1991b) Staphylococcal-enterotoxin- dependent cell-mediated cytotoxicity. Immunol Today 12: 147-150
14. Erlandsson E, Andersson K, Cavallin A, Nilsson A, Larsson-Lorek U, Niss U, Sjoberg A, Wallen-Ohman M, Antonsson P, Walse B, Forsberg G (2003) Identification of the antigenic epitopes in staphylococcal enterotoxins A and E and design of a superantigen for human cancer therapy. J Mol Biol 333: 893-905
15. Fischer H, Dohlsten M, Andersson U, Hedlund G, Ericsson P, Hansson J, Sjogren HO (1990) Production of TNF-alpha and TNF-beta by staphylococcal enterotoxin A activated human T cells. J Immunol 144: 4663-4669
16. Forsberg G, Ohlsson L, Brodin T, Bjork P, Lando PA, Shaw D, Stern PL, Dohlsten M (2001) Therapy of human non-small-cell lung carcinoma using antibody targeting of a modified superantigen. Br J Cancer 85: 129-136
17. Giantonio BJ, Alpaugh RK, Schultz J, McAleer C, Newton DW, Shannon B, Guedez Y, Kotb M, Vitek L, Persson R, Gunnarsson PO, Kalland T, Dohlsten M, Persson B, Weiner LM (1997) Superantigen-based immunotherapy: a phase I trial of PNU-214565, a monoclonal antibody-staphylococcal enterotoxin A recombinant fusion protein, in advanced pancreatic and colorectal cancer. J Clin Oncol 15: 1994-2007
18. Griffiths RW, Gilham DE, Dangoor A, Ramani V, Clarke NW, Stern PL, Hawkins RE (2005) Expression of the 5T4 oncofoetal antigen in renal cell carcinoma: a potential target for T-cell-based immunotherapy. Br J Cancer 93: 670-677
19. Hole N, Stern PL (1988) A 72 kD trophoblast glycoprotein defined by a monoclonal antibody. Br J Cancer 57: 239-246
20. Hole N, Stern PL (1990) Isolation and characterization of 5T4, a tumour-associated antigen. Int J Cancer 45: 179-184
21. Kricka LJ, Schmerfeld-Pruss D, Kaladas P, Colcher D, Scassellari GA (1993) Survey of methods for measuring human anti-mouse antibodies. HAMA Survey Group. Clin Chim Acta 215: 153-163
22. Litton MJ, Dohlsten M, Hansson J, Rosendahl A, Ohlsson L, Kalland T, Andersson J, Andersson U (1997) Tumor therapy with an antibody-targeted superantigen generates a dichotomy between local and systemic immune responses. Am J Pathol 150: 1607-1618
23. + T-cells during the anti-tumour effects of targeted superantigens. Br J Cancer 81: 359-366
24. Mekhail TM, Abou-Jawde RM, Boumerhi G, Malhi S, Wood L, Elson P, Bukowski R (2005) Validation and extension of the Memorial Sloan-Kettering prognostic factors model for survival in patients with previously untreated metastatic renal cell carcinoma. J Clin Oncol 23: 832-841
25. Mirick GR, Bradt BM, Denardo SJ, Denardo GL (2004) A review of human anti-globulin antibody (HAGA, HAMA, HACA, HAHA) responses to monoclonal antibodies. Not four letter words. Q J Nucl Med Mol Imaging 48: 251-257
26. Motzer RJ (2003) Prognostic factors and clinical trials of new agents in patients with metastatic renal cell carcinoma. Crit Rev Oncol Hematol 46: S33-S39
27. Motzer RJ, Bacik J, Schwartz LH, Reuter V, Russo P, Marion S, Mazumdar M (2004) Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J Clin Oncol 22: 454-463
28. Motzer RJ, Michaelson MD, Redman BG, Hudes GR, Wilding G, Figlin RA, Ginsberg MS, Kim ST, Baum CM, DePrimo SE, Li JZ, Bello CL, Theuer CP, George DJ, Rini BI (2006) Activity of SU11248, a multi-targeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol 24: 16-24
29. Motzer RJ, Russo P (2000) Systemic therapy for renal cell carcinoma. J Urol 163: 408-417
30. Mulders P, Figlin R, deKernion JB, Wiltrout R, Linehan M, Parkinson D, deWolf W, Belldegrun A (1997) Renal cell carcinoma: recent progress and future directions. Cancer Res 57: 5189-5195
31. O'Brien MF, Rea D, Rogers E, Bredin H, Butler M, Grainger R, McDermott TE, Mullins G, O'Brien A, Twomey A, Thornhill J (2004) Interleukin-2, interferon-alpha and 5-fluorouracil immunotherapy for metastatic renal cell carcinoma: the all Ireland experience. Eur Urol 45: 613-618; discussion 619
32. Patel PH, Chaganti RS, Motzer RJ (2006) Targeted therapy for metastatic renal cell carcinoma. Br J Cancer 94: 614-619
33. Petersson K, Forsberg G, Walse B (2004) Interplay between superantigens and immunoreceptors. Scand J Immunol 59: 345-355
34. Porta C, Zimatore M, Imarisio I, Natalizi A, Sartore-Bianchi A, Danova M, Riccardi A (2004) Gemcitabine and oxaliplatin in the treatment of patients with immunotherapy-resistant advanced renal cell carcinoma: final results of a single-institution Phase II study. Cancer 100: 2132-2138
35. Quinn MBP, Brock A, Kirby L, Jones J (2001) Cancer Trends in England and Wales 1950-1999. London: The Stationery Office
36. Rathmell WK, Malkowicz SB, Holroyde C, Luginbuhl W, Vaughn DJ (2004) Phase II trial of 5-fluorouracil and leucovorin in combination with interferon-alpha and interleukin-2 for advanced renal cell cancer. Am J Clin Oncol 27: 109-112
37. Rini BI, Sosman JA, Motzer RJ (2005) Therapy targeted at vascular endothelial growth factor in metastatic renal cell carcinoma: biology, clinical results and future development. BJU Int 96: 286-290
38. Rosendahl A, Hansson J, Sundstedt A, Kalland T, Dohlsten M (1996) Immune response during tumor therapy with antibody-superantigen fusion proteins. Int J Cancer 68: 109-113
39. Southall PJ, Boxer GM, Bagshawe KD, Hole N, Bromley M, Stern PL (1990) Immunohistological distribution of 5T4 antigen in normal and malignant tissues. Br J Cancer 61: 89-95
40. Waters JS, Moss C, Pyle L, James M, Hackett S, A'Hern R, Gore M, Eisen T (2004) Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma. Br J Cancer 91: 1763-1768
41. Yang JC, Sherry RM, Steinberg SM, Topalian SL, Schwartzentruber DJ, Hwu P, Seipp CA, Rogers-Freezer L, Morton KE, White DE, Liewehr DJ, Merino MJ, Rosenberg SA (2003) Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol 21: 3127-3132