Isolated limb perfusion with tumour necrosis factor-α and melphalan with or without interferon-γ for the treatment of in-transit melanoma metastases: A multicentre randomized phase II study

Melanoma Research

Volumn 9, Issue 5, 1999, Pages 491-502

  Lienard D ^a   Eggermont, A M M ^b   Schraffordt Knoops, H ^c   Kroon, B ^d   Towse, G ^e   Hiemstra, S ^e   Schmitz, P ^b   Clarke, J ^f   Steinmann, G ^f   Rosenkaimer, F ^f   Lejeune, F J ^a  

^a LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^d NETHERLANDS CANCER INSTITUTE   (Netherlands)

^e Pharmaceutical Research Associates   (Germany)

^f NONE

Author keywords

[No Author keywords available]

Indexed keywords

GAMMA INTERFERON; MELPHALAN; TUMOR NECROSIS FACTOR ALPHA;

ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RECURRENCE; CANCER SURVIVAL; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DRUG EFFICACY; FATIGUE; FEMALE; FEVER; HEADACHE; HEART ARRHYTHMIA; HUMAN; INTRAARTERIAL DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MELANOMA; METASTASIS; MULTICENTER STUDY; NAUSEA; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REGIONAL PERFUSION; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME; VOMITING;

EID: 0032695429     PISSN: 09608931     EISSN: None     Source Type: Journal    
DOI: 10.1097/00008390-199910000-00009     Document Type: Article

References (41)

1. Schraffordt Koops HS, Vaglini M, Suciu S, Kroon B, Thompson JF, Gohl J, Eggermont A, Difilippo F, Krementz ET, Ruiter D, Lejeune FJ. Prophylactic isolated limb perfusion for localized, high-risk limb melanoma - results of a multicenter randomized phase III trial. J Clin Oncol 1998; 16: 2906-2912.
2. Lejeune FJ. High dose recombinant tumour necrosis factor (rTNF alpha) administered by isolation perfusion for advanced tumours of the limbs: a model for biochemotherapy of cancer. Eur J Cancer 1995; 6: 1009-1016.
3. Carswell EA, Kassel RL. An endotoxin-induced serum factor that causes necrosis of tumors. Proc Natl Acad Sci USA 1975; 72: 3666-3670.
4. Old LJ. Tumor necrosis factor (TNF). Science 1985; 230: 630-632.
5. Glauser MP, Zanetti G, Baumgartner JD, Cohen J. Septic shock: pathogenesis, Lancet 1991; 338: 732-736.
6. Chapman PB, Lester TJ, Casper ES, Gabrilove JL, Wong GY, Kempin SJ, Gold PJ, Welt S, Warren RS, Starnes HF, et al. Clinical pharmacology of recombinant human tumor necrosis factor in patients with advanced cancer. J Clin Oncol 1987; 5: 1942-1951.
7. Feinberg B, Kurzrock R, Talpaz M, Blick M, Saks S, Gutterman JU. A phase I trial of intravenously-administered recombinant tumor necrosis factor-alpha in cancer patients. J Clin Oncol 1988; 6: 1328-1334.
8. Spriggs DR, Sherman ML, Michie H, Arthur KA, Imamura K, Wilmore D, Frei ED, Kufe DW. Recombinant human tumor necrosis factor administered as a 24-hour intravenous Infusion. A phase I and pharmacologic study. J Natl Cancer Inst 1988; 80: 1039-1044.
9. Carrel S, Schmidt-Kessen A, Giuffre L. Recombinant interferon-gamma can induce the expression of HLA-DR and -DC on DR-negative melanoma cells and enhance the expression of HLA-ABC and tumor-associated antigens. Eur J Immunol 1985; 15: 118-123.
10. Balkwill FR, Lee A, Aldam G, Moodie E, Thomas J A, Tavernier J, Fiers W. Human tumor xenografts treated with recombinant human tumor necrosis factor alone or in combination with interferons. Cancer Res 1986; 46: 3990-3993.
11. Haranaka K, Sakurai A, Satomi N. Antitumor activity of recombinant human tumor necrosis factor in combination with hyperthermia, chemotherapy, or immunotherapy. J Biol Response Modifiers 1987; 6: 379-391.
12. Marquet RL, Ijzermans JN, De Bruin RW, Fiers W, Jeekel J. Anti-tumor activity of recombinant mouse tumor necrosis factor (TNF) on colon cancer in rats is promoted by recombinant rat Interferon gamma; toxicity is reduced by indomethacin. Int J Cancer 1987; 40: 550-553.
13. Taguchi T, Kimoto Y, Tanji Y, Abe S, Nakano K, Sohmura Y. Augmentation of cytotoxic activity of recombinant human tumor necrosis factor (rHu-TNF) by recombinant human interferon-gamma (rHu-IFN-gamma). J Biol Response Modifiers 1987; 6: 599-609.
14. Manusama ER, Nooijen PT, Stavast J, Durante NM, Marquet RL, Eggermont AM. Synergistic antitumour effect of recombinant human tumour necrosis factor alpha with melphalan in isolated limb perfusion in the rat. Br J Surg 1996; 83: 551-555.
15. Nooijen PT, Manusama ER, Eggermont AM, Schalkwijk L, Stavast J, Marquet RL, de Waal RM, Ruiter DJ. Synergistic effects of TNF-alpha and melphalan in an isolated limb perfusion model of rat sarcoma: a histopathological, Immunohistochemical and electron microscopical study. Br J Cancer 1996; 74: 1908-1915.
16. Posner M, Lienard D, Lejeune F, Rosenfelder D, Kirkwood J. Hyperthermic isolated limb perfusion with tumor necrosis factor alone for melanoma. Cancer J Sci Am 1995; 1: 274-280.
17. Abbruzzese JL, Levin B, Ajani JA, Faintuch JS, Saks S, Patt YZ, Edwards C, Ende K, Gutterman JU. Phase I trial of recombinant human gamma-interferon and recombinant human tumor necrosis factor in patients with advanced gastrointestinal cancer. Cancer Res 1989; 49: 4057-4061.
18. Demetri GD, Spriggs DR, Sherman ML, Arthur KA, Imamura K, Kufe DW, A phase I trial of recombinant human tumor necrosis factor and interferon-gamma: effects of combination cytokine administration in vivo. J Clin Oncol 1989; 7: 1545-1553.
19. Atkins M, Trehu F., Mier J. Combination Cytokine Therapy. Biologic Therapy of Cancer, 2nd edn. Philadelphia: JB Lippincott, l995: 443-466.
20. Krosnick JA, Mule JJ, McIntosh JK, Rosenberg SA. Augmentation of antitumor efficacy by the combination of recombinant tumor necrosis factor and chemotherapeutic agents in vivo Cancer Res 1989; 49: 3729-3733.
21. Watanabe N, Niitsu Y, Umeno H, Sone H, Neda H, Yamauchi N, Maeda M, Urushizaki I. Synergistic cytotoxic and antitumor effects of recombinant human tumor necrosis factor and hyperthermia. Cancer Res 1988; 48: 650-653.
22. Niitsu Y, Watanabe N, Umeno H, Sone H, Neda H, Yamauchi N, Maeda M, Urushizaki I. Synergistic effects of recombinant human tumor necrosis factor and hyperthermia on in vitro cytotoxicity and artificial metastasis. Cancer Res 1988; 18: 654-657.
23. Wu ZY, Smithers BM, Roberts MS. Melphalan dosing regimens for management of recurrent melanoma by isolated limb perfusion: application of a physiological pharmacokinetic model based on melphalan distribution in the isolated perfused rat hindlimb. Melanoma Res 1997; 7: 252-264.
24. Lejeune F, Lienard D, Eggermont A, Schraffordt Koops H, Rosenkaimer F, Gerain J, Klaase J, Kroon B, Vanderveken J, Schmitz P. Administration of high-dose tumor necrosis factor alpha by isolation perfusion of the limbs. Rationale and results. J Infustional Chemother 1995; 5: 73-81.
25. Lienard D, Ewalenko P, Delmotte JJ, Renard N, Lejeune FJ. High-dose recombinant tumor necrosis factor alpha in combination with interferon gamma and melphalan in isolation perfusion of the limbs for melanoma and sarcoma. J Clin Oncol 1992; 10: 52-60.
26. Lienard D, Eggermont AM, Schraffordt Koops H, Kroon BB, Rosenkaimer F, Autier P, Lejeune FJ. Isolated perfusion of the limb with high-dose tumour necrosis factor-alpha (TNF-alpha), interferon-gamma (IFN-gamma) and melphalan for melanoma stage III. Results of a multi-centre pilot study. Melanoma Res 1994; 1: 21-26.
27. Di Filippo F, Rossi CR, Cavaliere F, Schiratti M, Vecchiato A, Lise M, Cavadiere R, Hyperthermic antiblastic perfusion with TNF-alpha and L-Pam in patients with stage II, IIIA and IIIAB limb melanoma. Melanoma Res 1997; 7: S832-S833.
28. Gutman M, Abu-Abid S, Inbar M, Klausner JM. Isolated limb perfusion (ILP) with tumour necrosis factor (TNF) and melphalan for locally advanced malignant melanoma. Eur J Surg Oncol 1998; 24: 213(abstract).
29. Kettelhack C, Hohenberger P, Schlag PM. [Isolated hyperthermic perfusion of extremities in malignant melanoma with melphalan and tumor necrosis factor] [German]. Langenbecks Arcb Cbir-Suppl-Kongressband 1996; 113: 127-129.
30. Wieberdink J, Benckhuysen C., Braat RP, van Slooten EA, Olthuis GA. Dosimetry in isolation perfusion of the limbs by assessment of perfused tissue volume and grading of toxic tissue reactions. Eur J Cancer Clin Oncol 1982; 18: 905-910.
31. World Health Organization. WHO Handbook for Reporting Results of Cancer Treatment, Geneva: World Health Organization, 1979.
32. Fraker DL. What is the best regional therapy? Melanoma Res 1997; 7: S42(abstract).
33. Eggermont AM, Schraffordt Koops H, Klausner JM, Kroon BB, Schlag PM, Lienard D, van Geel AN, Hoekstra HJ, Meller I, Nieweg OE, Kettelhack C, Ben-Ari G, Pector JC, Lejeune FJ. Isolated limb perfusion with tumor necrosis factor and melphalan for limb salvage in 186 patients with locally advanced soft tissue extremity sarcomas. The cumulative multicenter European experience. Ann Surg 1996; 224: 756-764.
34. Lejeune F, Ruegg C, Lienard D. Clinical applications of TNF-alpha in cancer Curr Opin Immunol 1998; 10: 573-580.
35. Dighe AS, Richards E, Old LJ, Schreiber RD. Enhanced in vivo growth and resistance to rejection of tumor cells expressing dominant negative IFN gamma receptors. Immunity 1994; 1: 447-456.
36. Bartlett DL, Ma G, Alexander HR, Libutti SK, Fraker DL. Isolated limb reperfusion with tumor necrosis factor and mclphalan in patients with extremity melanoma after failure of isolated limb perfusion with chemotherapeutics. Cancer 1997; 80: 2084-2090.
37. Di Filippo F, Calabro A, Giannarelli D, Carlini S, Cavaliere F, Moscarelli F, Cavaliere R. Prognostic variables in recurrent limb melanoma treated with hyperthermic antiblastic perfusion. Cancer 1989; 63: 2551-2561.
38. Eggermont AM, Schraffordt Koops H, Lienard D, Kroon BB, van Geel AN, Hoekstra HJ, Lejeune FJ. Isolated limb perfusion with high-dose tumor necrosis factor-alpha in combination with interferon-gamma and melphalan for nonresectable extremity soft tissue sarcomas: a multicenter trial. J Clin Oncol 1996; 14: 2653-2665.
39. Renard N, Lienard D, Lespagnard L., Eggermont A, Heimann R, Lejeune F. Early endothelium activation and polymorphonuclear cell invasion precede specific necrosis of human melanoma and sarcoma treated by intravascular high-dose tumour necrosis factor alpha (rTNF alpha). Int J Cancer 1994; 57: 656-663.
40. Renard N, Nooijen PT, Schalkwijk L, De Waal RM, Eggermont AM, Lienard D, Kroon BB, Lejeune FJ, Ruiter DJ. VWF release and platelet aggregation in human melanoma after perfusion with TNF alpha. J Pathol 1995; 176: 279-287.
41. Ruegg C, Bieler G, Bamat J, Chaubert P, Lejeune FJ. Evidence for the involvement of endothelial cell integrin alphaVbeta3 in the disruption of the tumor vasculatre induced by TNF and IFN gamma. Nature Med 1998; 4: 108-414.