Randomized phase II trial of BCDT [carmustine (BCNU), cisplatin, dacarbazine (DTIC) and tamoxifen] with or without interferon alpha (IFN-α) and interleukin (IL-2) in patients with metastatic melanoma

British Journal of Cancer

Volumn 77, Issue 8, 1998, Pages 1280-1286

  Johnston, S R D ^a   Constenla, D O ^a   Moore, J ^a   Atkinson, H ^a   A'Hern, R P ^a   Dadian, G ^b   Riches, P G ^b   Gore, M E ^a  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

Biochemotherapy; Immune activation; Interferon alpha; Interleukin 2; Melanoma

Indexed keywords

ALPHA INTERFERON; CARMUSTINE; CD3 ANTIGEN; CD4 ANTIGEN; CD56 ANTIGEN; CISPLATIN; DACARBAZINE; HLA DR ANTIGEN; INTERLEUKIN 2; TAMOXIFEN;

ADULT; AGED; ANEMIA; ARTICLE; BONE METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; EDEMA; FATIGUE; FEMALE; FLOW CYTOMETRY; HUMAN; IMMUNE RESPONSE; INTRAVENOUS DRUG ADMINISTRATION; LIVER METASTASIS; LUNG METASTASIS; LYMPH NODE METASTASIS; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MELANOMA; METASTASIS; NAUSEA; ORAL DRUG ADMINISTRATION; PERIPHERAL LYMPHOCYTE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN METASTASIS; SUBCUTANEOUS DRUG ADMINISTRATION; SURVIVAL TIME; T LYMPHOCYTE ACTIVATION; THROMBOCYTOPENIA; VOMITING; WEIGHT REDUCTION;

EID: 0031936639     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/bjc.1998.214     Document Type: Article

References (28)

1. Atzpodien J, Korfer A, Franks CR, Poliwoda H and Kirchner H (1990) Home therapy with recombinant interleukin-2 and interferon-α2b in advanced human malignancies. Lancet 335: 1509-1512
2. Atzpodien J, Kirchner H, Korfer A, Hadman M, Schomburg A, Menzel T, Deckert M, Franzke A, Volkenandi M, Dallmann I, Grosse J and Poliwoda H (1993) Expansion of peripheral blood natural killer cells correlates with clinical outcome in cancer patients receiving recombinant subcutaneous interleukin-2 and interferon-alpha-2. Tumour Biol 14: 354
3. Atzpodien J, Hanninen EL, Kirchner H, Bodenstein H, Pfreundschuh M, Rebmann U, Metzner B, Illiger HJ, Jaske G, Niesel T, Scholz HJ, Wilhelm S, Pielmeier T, Zakrzewski G, Blum G, Beier J, Muller GW, Duensing S, Anton P, Allhoff E, Jonas U and Poliwada H (1995) Multi-institutional home-therapy trial of recombinant human interleukin-2 and interferon alfa-2 in progressive metastatic renal cell carcinoma. J Clin Oncol 13: 497-501
4. Bajelta E, Di-Leo A, Zampino MG, Sertoli MR, Comella G, Barduagni M, Giannotti B, Queirolo P, Tribbia G, Bernengo MG, Menichetti ET, Palmeri S, Russo A, Cristofolini M, Erbazzi A, Fowst C, Criscuolo D, Bufalino R and Zilembo N (1994) Multicenter randomized trial of dacarbazine alone or in combination with two different doses and schedules of interferon alfa-2a in the treatment of advanced melanoma. J Clin Oncol 12: 806
5. Buter J, Sleijfer DT, Winette TA, De Vries EGE, Willemse PHB and Mulder NH (1993) A progress report on the outpatient treatment of patients with advanced renal cell carcinoma using subcutaneous recombinant interleukin-2. Semin Oncol 20: 16-21
6. Caliguri MA (1993) Low-dose recombinant interleukin-2 therapy: rationale and potential clinical applications. Semin Oncol 20 (suppl 9): 3-10
7. Castello G, Comella P, Manzo T, Napolitano M, Parziale AP, Galati MG, Daponte A, Casaretti R, Celentano E and Comella G (1993) Immunological or clinical effects of intramuscular rIFN alpha-2a and low dose subcutaneous rIL-2 in patients with advanced malignant melanoma. Melanoma Res 3: 43
8. Dadian G, Riches PG, Henderson DC, Taylor A, Moore J, Atkinson H and Gore ME (1993) Immune changes in peripheral blood resulting from locally directed interleukin-2 therapy in squamous cell carcinoma of the head and neck. Oral Oncol Eur J Cancer 29b: 29-34
9. DelPrete SA, Maurer LH, O'Donnell J, Forcler RJ and LeMarbre P (1994) Combination chemotherapy with cisplatin. carmustine, dacarbazine, and tamoxifen in metastatic melanoma. Cancer Treat Rep 68: 1403-1405
10. Demchak PA, Mier JW, Robert NJ, O'Brien K, Gould JA and Atkins MB (1991) Interleukin-2 and high-dose cisplatin in patients with metastatic melanoma: a pilot study. J Clin Oncol 9: 1821-1830
11. Dillman RO, Oldham RK, Barth NM, Birch R, Arnold J and West WH (1990) Recombinant interleukin-2 and adoptive immunotherapy alternated with dacarbazine therapy in melanoma: a national biotherapy study group trial. J Natl Cancer Inst 82: 1345
12. Falkson CI, Falkson G and Falkson HC (1991) Improved results with the addition of interferon alpha-2b to dacarbazine in the treatment of patients with metastatic melanoma. J Clin Oncol 9: 1403
13. Flaherty LE, Redman BG, Chabot GG, Martino S, Gualdoni SM and Heilbrun LK (1990) A phase I-II study of dacarbazine in combination with outpatient interleukin-2 in metastatic malignant melanoma. Cancer 65: 2471-2477
14. Flaherty LE, Robinson W, Redman BG, Gonzalez R, Martino S, Kraut M, Valdivieso M and Rudolph AR (1993) A phase II study of dacarbazine and cisplatin in combination with outpatient administered interleukin-2 in metastatic malignant melanoma. Cancer 71: 3520
15. Keilholtz U, Goey FH, Puni CJA, Proebstle T, Salzmann R, Schadendorf D, Lienard D, Scheibenbogen C and Eggermont AMM (1996) A randomised trial of IFNα/IL-2 with and without cisplatin in advanced melanoma: EORTC melanoma cooperative group trial (abstract 1353). Proc Am Soc Clin Oncol 15: 436
16. Kirkwood JM, Strawderman MH, Ernstoff MS, Smith TJ, Borden EC and Blum RH (1996) Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: The Eastern Cooperative Oncology Group Trial EST 1684. J Clin Oncol 14: 7-17
17. Lakhani S, Selby P, Bliss JM, Perren TJ, Gore ME and McElwain TJ (1990) Chemotherapy for malignant melanomas: combination and high doses produce more response without survival benefit. Br J Cancer 61: 330-334
18. Legha SS and Buzaid AC (1993) Role of recombinant interleukin-2 in combination with interferon-alfa and chemotherapy in the treatment of advanced melanoma. Semin Oncol 20 (suppl. 9): 27-32
19. Legha SS, Ring S, Bedikian A, Plager C, Eton O, Buzaid AC and Papadopoulos N (1996) Treatment of metastatic melanoma with combined chemotherapy containing cisplatin, vinblastine and dacarbazine (CVD) and biotherapy using interleukin-2 and interferon alpha. Ann Oncol 7: 827-835
20. Mastrangelo MJ, Nathan F, Faguire HC, et al (1993) Trials with combination chemotherapy and active specific immunotherapy. Melanoma Res 3: 33
21. Richards JM, Mehta N, Ramming K, et al (1992) Sequential chemoimmunotherapy in the treatment of metastatic melanoma. J Clin Oncol 10: 1338-1343
22. Rosenberg SA, Lotze MT, Yang JC, Lineham WM, Seipp C, Calabro S, Karp SE, Sherry RM, Steinberg S and White DE (1989) Combination therapy with interleukin-2 and alpha-interferon for the treatment of patients with advanced malignant melanoma. J Clin Oncol 7: 1863-1874
23. Rosenberg SA, Lotze MT, Yang JC, Topalian SL, Chang AE, Schwartzentruber DJ, Aebersold P, Leitman S, Lineham WM, Seipp CA, White DE and Steinberg SM (1943) Prospective randomised trial of high-dose interleukin-2 alone or in conjunction with lymphokine-activated killer cells for the treatment of patients with advanced cancer. J Natl Cancer Inst 622-632
24. Rumpke PH (1984) The use of chemotherapy in the management of patients with malignant melanoma. Clin Oncol 3: 555-570
25. Rusthoven JJ, Quirt IC, Iscoe NA, McCulloch PB, James KW, Lohman RC, Jensen J, Burdette-Radoux S, Bodurtha AJ, Silver HKB, Verma S, Armitage GR, Zee B and Bennet K (1996) Randomized. double-blind, placebo-controlled trial comparing the response rates of carmustine, dacarbazine, and cisplatin with and without tamoxifen in patients with metastatic melanoma. J Clin Oncol 14: 2083-2090
26. Sparano JA, Fisher RI, Sunderland M, Margolin K, Ernest ML, Sznol M, Atkins MB, Dutcher JP, Micetich KC, Weiss GR, Doroshow JH, Aronson FR, Rubinstein LV and Mier JW (1993) Randomised phase III trial of treatment with high-dose interleukin-2 either alone or in combination with interferon alpha-2a in patients with advanced melanoma. J Clin Oncol 11: 1969
27. Stoter G, Aamdal S, Rodenhuis S, Cleton FJ, Iacobelli S, Franks CR, Oskam R and Shiloni E (1991) Sequential administration of recombinant human interleukin-2 and dacrabazine in metastatic melanoma: a multicenter phase II study. J Clin Oncol 9: 1687-1691
28. Thomson DB, Adena M, MeLeod GR, Hersey P, Gill PG, Coates AS, Olver IN, Kefford RF, Lowenthal RM, Beadle GF, Walpole ET, Boland K and Kingston D (1993) Interferon-alpha 2a does not improve response or survival when combined with dacarbazine in metastatic malignant melanoma: results of a multi-institutional Australian randomized trial. Melanoma Res 3: 133