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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-18951 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.
Patients are followed every 2 months for 6 months, then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | |||
| recombinant interferon alfa | Biological | |||
| cisplatin | Drug | |||
| dacarbazine | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma that is metastatic and unresectable
Measurable, progressive disease (by physical exam and/or noninvasive imaging)
No CNS metastases (confirmed by CT or MRI)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Keilholz, MD | Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenanstalten - Salzburg | Salzburg | A-5020 | Austria | |||
| Hopital Universitaire Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19419855 | Background | Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, Stein CA, Itri LM, Suciu S, Eggermont AM. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer. 2009 Jul;45(10):1807-14. doi: 10.1016/j.ejca.2009.04.016. Epub 2009 May 4. | |
| Background | Keilholz U, Suciu S, Bedikian AY, et al.: LDH is a prognostic factor in stage IV melanoma patients (pts) but is a predictive factor only for bcl2 antisense treatment efficacy: re-analysis of GM301 and EORTC18951 randomized trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-8552, 485s, 2007. | ||
| 10685668 |
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| Brussels |
| 1070 |
| Belgium |
| Institut Jules Bordet | Brussels (Bruxelles) | 1000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| CHR de Besancon - Hopital Saint-Jacques | Besançon | 25030 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| CHU Pitie-Salpetriere | Paris | 75651 | France |
| Universitaetsklinikum Charite | Berlin | D-10117 | Germany |
| Universitaetsklinikum Benjamin Franklin | Berlin | D-12200 | Germany |
| Robert Roessle Klinik | Berlin | D-13122 | Germany |
| Haematologisch-Onkologische Praxis Altona | Hamburg | D-22765 | Germany |
| Johannes Gutenberg University | Mainz | D-55101 | Germany |
| III Medizinische Klinik Mannheim | Mannheim | D-68135 | Germany |
| Istituto Europeo Di Oncologia | Milan | 20141 | Italy |
| University Medical Center Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| Rotterdam Cancer Institute | Rotterdam | 3075 EA | Netherlands |
| Instituto Portugues de Oncologia do Porto | Porto | 4200 | Portugal |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Universitaetsspital | Zurich | CH-8091 | Switzerland |
| St. James's Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Royal Marsden NHS Trust | London | England | SW3 6JJ | United Kingdom |
| Southend NHS Trust Hospital | Westcliff-on-Sea | England | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Background |
| Keilholz U, Eggermont AM. The role of interleukin-2 in the management of stage IV melanoma: the EORTC melanoma cooperative group program. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S99-103. |
| 17443000 | Result | Schmidt H, Suciu S, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, von der Maase H, Eggermont AM, Keilholz U; American Joint Committee on Cancer Stage IV Melanoma; EORTC 18951. Pretreatment levels of peripheral neutrophils and leukocytes as independent predictors of overall survival in patients with American Joint Committee on Cancer Stage IV Melanoma: results of the EORTC 18951 Biochemotherapy Trial. J Clin Oncol. 2007 Apr 20;25(12):1562-9. doi: 10.1200/JCO.2006.09.0274. |
| 17023156 | Result | Punt CJ, Suciu S, Gore MA, Koller J, Kruit WH, Thomas J, Patel P, Lienard D, Eggermont AM, Keilholz U. Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group. Eur J Cancer. 2006 Nov;42(17):2991-5. doi: 10.1016/j.ejca.2006.08.012. Epub 2006 Oct 4. |
| 16170182 | Result | Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2005 Sep 20;23(27):6747-55. doi: 10.1200/JCO.2005.03.202. |
| Result | Keilholz U, Punt CJ, Gore M, et al.: Dacarbazine, cisplatin and interferon alpha with or without interleukin-2 in advanced melanoma: interim analysis of EORTC trial 18951. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2043, 530a, 1999. |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D016898 | Interferon-alpha |
| D002945 | Cisplatin |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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