Two randomised phase II trials of subcutaneous interleukin-2 and histamine dihydrochloride in patients with metastatic renal cell carcinoma

British Journal of Cancer

Volumn 93, Issue 7, 2005, Pages 757-762

  Donskov, F ^a   Middleton, M ^b,c   Fode, K ^a   Meldgaard, P ^a   Mansoor, W ^b   Lawrance, J ^b   Thatcher, N ^b   Nellemann, H ^a   Von Der Maase, H ^a  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b CHRISTIE HOSPITAL   (United Kingdom)

^c CHURCHILL HOSPITAL   (United Kingdom)

Author keywords

Histamine dihydrochloride; Interleukin 2; Oxidative stress; Randomised; Renal cell carcinoma

Indexed keywords

HISTAMINE; RECOMBINANT INTERLEUKIN 2;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; AGED; AMNESIA; ANOREXIA; ARTICLE; BRONCHOSPASM; CANCER SURVIVAL; CLINICAL TRIAL; CONFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CREATININE BLOOD LEVEL; DEHYDRATION; DENMARK; DIARRHEA; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DYSPNEA; EDEMA; FACE EDEMA; FEMALE; FLU LIKE SYNDROME; HEADACHE; HUMAN; HYPERKALEMIA; HYPOTENSION; INJECTION SITE REACTION; INTESTINE INFARCTION; KIDNEY CARCINOMA; LETHARGY; MAJOR CLINICAL STUDY; MALE; METASTASIS; NAUSEA; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SIDE EFFECT; STATISTICAL SIGNIFICANCE; STOMATITIS; THROMBOCYTOPENIA; TREMOR; UNITED KINGDOM; URTICARIA; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; CARCINOMA, RENAL CELL; FEMALE; HISTAMINE; HUMANS; INJECTIONS, SUBCUTANEOUS; INTERLEUKIN-2; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; OXIDATIVE STRESS; SURVIVAL ANALYSIS;

EID: 27144501804     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6602768     Document Type: Article

References (38)

1. Agarwala SS, Glaspy J, O'Day SJ, Mitchell M, Gutheil J, Whitman E, Gonzalez R, Hersh E, Feun L, Belt R, Meyskens F, Hellstrand K, Wood D, Kirkwood JM, Gehlsen KR, Naredi P (2002) Results from a randomized phase III study comparing combined treatment with histamine dihydrochloride plus interleukin-2 vs interleukin-2 alone in patients with metastatic melanoma. J Clin Oncol 20: 125-133
2. Agarwala SS, Hellstrand K, Gehlsen K, Naredi P (2004) Immunotherapy with histamine and interleukin 2 in malignant melanoma with liver metastasis. Cancer Immunol Immunother 53: 840-841
3. Asea A, Hermodsson S, Hellstrand K (1996) Histaminergic regulation of natural killer cell-mediated clearance of tumour cells in mice. Scand J Immunol 43: 9-15
4. Atzpodien J, Hoffmann R, Franzke M, Stief C, Wandert T, Reitz M (2002) Thirteen-year, long-term efficacy of Interferon 2alpha and interleukin 2-based home therapy in patients with advanced renal cell carcinoma. Cancer 95: 1045-1050
5. Bordin V, Giani L, Meregalli S, Bukovec R, Vaghi MM, Mandala M, Paolorossi F, Ardizzoia A, Tancini G, Barni S, Frigerio F, Fumagalli L, Bordoni A, Valsuani G, Di Felice G, Lissoni P (2000) Five-year survival results of subcutaneous low-dose immunotherapy with interleukin-2 alone in metastatic renal cell cancer patients. Urol Int 64: 3-8
6. Brune M, Hellstrand K (1996) Remission maintenance therapy with histamine and interleukin-2 in acute myelogenous leukaemia. Br J Haematol 92: 620-626
7. Donskov F, Bennedsgaard KM, Hokland M, Marcussen N, Fisker R, Madsen HH, Fode K, von der Maase H (2004) Leukocyte orchestration in blood and tumour tissue following interleukin-2 based immunotherapy in metastatic renal cell carcinoma. Cancer Immunol Immunother 53: 729-739
8. Donskov F, von der Maase H, Henriksson R, Stierner U, Wersall P, Nellemann H, Hellstrand K, Engman K, Naredi P (2002) Outpatient treatment with subcutaneous histamine dihydrochloride in combination with interleukin-2 and interferon-alpha in patients with metastatic renal cell carcinoma: results of an open single-armed multicentre phase II study. Ann Oncol 13: 441-449
9. Elson PJ, Witte RS, Trump DL (1988) Prognostic factors for survival in patients with recurrent or metastatic renal cell carcinoma. Cancer Res 48: 7310-7313
10. Finke JH, Zea AH, Stanley J, Longo DL, Mizoguchi H, Tubbs RR, Wiltrout RH, O'Shea JJ, Kudoh S, Klein E (1993) Loss of T-cell receptor zeta chain and p56lck in T-cells infiltrating human renal cell carcinoma. Cancer Res 53: 5613-5616
11. Fisher RI, Rosenberg SA, Fyfe G (2000) Long-term survival update for high-dose recombinant interleukin-2 in patients with renal cell carcinoma. Cancer J Sci Am 6(Suppl 1): S55-S57
12. Haas GP, Hillman GG, Redman BG, Pontes JE (1993) Immunotherapy of renal cell carcinoma. CA Cancer J Clin 43: 177-187
13. Hansson M, Asea A, Ersson U, Hermodsson S, Hellstrand K (1996a) Induction of apoptosis in NK cells by monocyte-derived reactive oxygen metabolites. J Immunol 156: 42-47
14. Hansson M, Asea A, Hermodsson S, Hellstrand K (1996b) Histaminergic regulation of NK-cells: protection against monocyte-induced apoptosis. Scand J Immunol 44: 193-196
15. Hansson M, Hermodsson S, Brune M, Mellqvist UH, Naredi P, Betten A, Gehlsen KR, Hellstrand K (1999) Histamine protects T cells and natural killer cells against oxidative stress. J Interferon Cytokine Res 19: 1135-1144
16. Hellstrand K (2002) Histamine in cancer immunotherapy: a preclinical background. Semin Oncol 29: 35-40
17. Hellstrand K, Asea A, Dahlgren C, Hermodsson S (1994a) Histaminergic regulation of NK cells. Role of monocyte-derived reactive oxygen metabolites. J Immunol 153: 4940-4947
18. Hellstrand K, Asea A, Hermodsson S (1990) Role of histamine in natural killer cell-mediated resistance against tumor cells. J Immunol 145: 4365-4370
19. Hellstrand K, Asea A, Hermodsson S (1994b) Histaminergic regulation of antibody-dependent cellular cytotoxicity of granulocytes, monocytes, and natural killer cells. J Leukoc Biol 55: 392-397
20. Hellstrand K, Brune M, Dahlgren C, Hansson M, Hermodsson S, Lindner P, Mellqvist UH, Naredi P (2000) Alleviating oxidative stress in cancer immunotherapy: a role for histamine? Med Oncol 17: 258-269
21. Hellstrand K, Hermodsson S (1986) Histamine H2-receptor-mediated regulation of human natural killer cell activity. J Immunol 137: 656-660
22. Hellstrand K, Hermodsson S (1990) Synergistic activation of human natural killer cell cytotoxicity by histamine and interleukin-2. Int Arch Allergy Appl Immunol 92: 379-389
23. Hellstrand K, Hermodsson S (1991) Cell-to-cell mediated inhibition of natural killer cell proliferation by monocytes and its regulation by histamine H2-receptors. Scand J Immunol 34: 741-752
24. Kono K, Salazar-Onfray F, Petersson M, Hansson J, Masucci G, Wasserman K, Nakazawa T, Anderson P, Kiessling R (1996) Hydrogen peroxide secreted by tumor-derived macrophages down-modulates signal-transducing zeta molecules and inhibits tumor-specific T cell- and natural killer cell-mediated cytotoxicity. Eur J Immunol 26: 1308-1313
25. Lurie Y, Nevens F, Aprosina ZG, Fedorova TA, Kalinin AV, Klimova EA, Ilan Y, Maevskaya MV, Warnes TW, Yuschuk ND, Hellstrand K, Gehlsen KR (2002) A multicentre, randomized study to evaluate the safety and efficacy of histamine dihydrochloride and interferon-alpha-2b for the treatment of chronic hepatitis C. J Viral Hepat 9: 346-353
26. McDermott DF, Regan MM, Clark JI, Flaherty LE, Weiss GR, Logan TF, Kirkwood JM, Gordon MS, Sosman JA, Ernstoff MS, Tretter CP, Urba WJ, Smith JW, Margolin KA, Mier JW, Gollob JA, Dutcher JP, Atkins MB (2005) Randomized phase III trial of high-dose interleukin-2 vs subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol 23: 133-141
27. Mellqvist UH, Wallhult E Brune M, Jacobsson S, Hellstrand K (1999) Histamine dihydrochloride, interleukin-2 and interferon-alfa in multiple myeloma. Int J Immunother 15: 125-130
28. Miller AB, Hoogstraten B, Staquet M, Winkler A (1981) Reporting results of cancer treatment. Cancer 47: 207-214
29. Motzer RJ, Russo P (2000) Systemic therapy for renal cell carcinoma. J Urol 163: 408-417
30. Negrier S, Escudier B, Lasset C, Douillard JY, Savary J, Chevreau C, Ravaud A, Mercatello A, Peny J, Mousseau M, Philip T, Tursz T (1998) Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie. N Engl J Med 338: 1272-1278
31. Negrier S, Maral J, Drevon M, Vinke J, Escudier B, Philip T (2000) Long-term follow-up of patients with metastatic renal cell carcinoma treated with intravenous recombinant interleukin-2 in Europe. Cancer J Sci Am 6(Suppl 1): S93-S98
32. O'Byrne KJ, Dalgleish AG (2001) Chronic immune activation and inflammation as the cause of malignancy. Br J Cancer 85: 473-483
33. Pollard JW (2004) Tumour-educated macrophages promote tumour progression and metastasis. Nat Rev Cancer 4: 71-78
34. Saio M, Radoja S, Marino M, Frey AB (2001) Tumor-infiltrating macrophages induce apoptosis in activated CD8(+) T cells by a mechanism requiring cell contact and mediated by both the cell-associated form of TNF and nitric oxide. J Immunol 167: 5583-5593
35. Schmidt H, Larsen S, Bastholt L, Fode K, Rytter C, von der Maase H (2002) A phase II study of outpatient subcutaneous histamine dihydrochloride, interleukin-2 and interferon-alpha in patients with metastatic melanoma. Ann Oncol 13: 1919-1924
36. Seaman WE, Gindhart TD, Blackman MA, Dalal B, Talal N, Werb Z (1982) Suppression of natural killing in vitro by monocytes and polymorphonuclear leukocytes: requirement for reactive metabolites of oxygen. J Clin Invest 69: 876-888
37. Tartour E, Latour S, Mathiot C, Thiounn N, Mosseri V, Joyeux I, D'Enghien CD, Lee R, Debre B, Fridman WH (1995) Variable expression of CD3-zeta chain in tumor-infiltrating lymphocytes (TIL) derived from renal-cell carcinoma: relationship with TIL phenotype and function. Int J Cancer 63: 205-212
38. Vakkila J, Lotze MT (2004) Inflammation and necrosis promote tumour growth. Nat Rev Immunol 4: 641-648