Phase I-II study of plitidepsin and dacarbazine as first-line therapy for advanced melanoma

British Journal of Cancer

Volumn 109, Issue 6, 2013, Pages 1451-1459

  Plummer, R ^a   Lorigan, P ^b   Brown, E ^c   Zaucha, R ^d   Moiseyenko, V ^e   Demidov, L ^f   Soriano, V ^g   Chmielowska, E ^h   Andres R ⁱ   Kudryavtseva, G ^j   Kahatt, C ^k   Szyldergemajn, S ^k   Extremera, S ^k   De Miguel, B ^k   Cullell Young, M ^k   Calvert, H ^a  

^a FREEMAN HOSPITAL   (United Kingdom)

^b CHRISTIE HOSPITAL   (United Kingdom)

^c WESTERN GENERAL HOSPITAL   (United Kingdom)

^d MEDICAL UNIVERSITY OF GDANSK   (Poland)

^e N N PETROV RESEARCH INSTITUTE OF ONCOLOGY   (Russian Federation)

^f N N BLOKHIN RUSSIAN CANCER RESEARCH CENTER   (Russian Federation)

^g INSTITUTO VALENCIANO DE ONCOLOGÍA   (Spain)

^h Regional Oncology Centre Bydgoszcz   (Poland)

ⁱ HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA   (Spain)

^j MEDICAL RADIOLOGICAL RESEARCH CENTER   (Russian Federation)

^k PHARMAMAR S A   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMINOTRANSFERASE; BILIRUBIN; DACARBAZINE; DEHYDRODIDEMNIN B; LACTATE DEHYDROGENASE;

ADULT; ADVANCED CANCER; AGED; ALLERGIC REACTION; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; BILIRUBIN BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DRUG RESPONSE; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERSENSITIVITY; LACTATE DEHYDROGENASE BLOOD LEVEL; LYMPHOCYTOPENIA; MALE; MELANOMA; MULTIPLE CYCLE TREATMENT; NAUSEA; PANCYTOPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; RESPIRATORY TRACT INFECTION; SEPSIS; SIDE EFFECT; VOMITING; WEAKNESS;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DACARBAZINE; DEPSIPEPTIDES; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MELANOMA; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84884586512     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2013.477     Document Type: Article

References (37)

1. Agarwala SS (2009) Current systemic therapy for metastatic melanoma. Expert Rev Anticancer Ther 9: 587-595.
2. Agarwala SS, Ferri W, Gooding W, Kirkwood JM (1999) A phase III randomized trial of dacarbazine and carboplatin with and without tamoxifen in the treatment of patients with metastatic melanoma. Cancer 85: 1979-1984.
3. Anthoney A, Paz-Ares L, Twelves C, Cortes-Funes H, Kaye S, Pronk L, Celli N, Lopez-Lazaro L, Guzman C, Jimeno J (2000) Phase I and pharmacokinetic (PK) study of Aplidin (APL) using a 24-hour, weekly schedule. Proc Am Soc Clin Oncol 19: Abstract 734.
4. Avril MF, Aamdal S, Grob JJ, Hauschild A, Mohr P, Bonerandi JJ, Weichenthal M, Neuber K, Bieber T, Gilde K, Guillem Porta V, Fra J, Bonneterre J, Saiag P, Kamanabrou D, Pehamberger H, Sufliarsky J, Gonzalez Larriba JL, Scherrer A, Menu Y (2004) Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: A phase III study. J Clin Oncol 22: 1118-1125.
5. Balch CM, Buzaid AC, Soong SJ, Atkins MB, Cascinelli N, Coit DG, Fleming ID, Gershenwald JE, Houghton Jr A, Kirkwood JM, McMasters KM, Mihm MF, Morton DL, Reintgen DS, Ross MI, Sober A, Thompson JA, Thompson JF (2003) New TNM melanoma staging system: Linking biology and natural history to clinical outcomes. Semin Surg Oncol 21: 43-52.
6. Bedikian AY, Johnson MM, Warneke CL, Papadopoulos NE, Kim K, Hwu WJ, McIntyre S, Hwu P (2008) Prognostic factors that determine the long-term survival of patients with unresectable metastatic melanoma. Cancer Invest 26: 624-633.
7. Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG (2006) Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: The Oblimersen Melanoma Study Group. J Clin Oncol 24: 4738-4745.
8. Buesa JM, Urrechaga E (1991) Clinical pharmacokinetics of high-dose DTIC. Cancer Chemother Pharmacol 28: 475-479.
9. Celli N, Mariani B, Di Carlo F, Zucchetti M, Lopez-Lazaro L, D'Incalci M, Rotilio D (2004) Determination of aplidin (dehydrodidemnin B) in human plasma, whole blood and urine by liquid chromatography with electrospray ionisation tandem mass spectrometry detection. J Pharm Biomed Anal 34: 619-630.
10. Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, Begg CB, Agarwala SS, Schuchter LM, Ernstoff MS, Houghton AN, Kirkwood JM (1999) Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol 17: 2745-2751.
11. Chapman PB, Hauschild A, Robert C, Larkin JMG, JBAG Haanen, Ribas A, Hogg D, Hamid O, Ascierto PA, Testori A, Lorigan P, Dummer R, Sosman JA, Garbe C, Maio M, Nolop KB, Nelson BJ, Joe AK, Flaherty KT, McArthur GA (2012) Updated overall survival (OS) results for BRIM-3, a phase III randomized, open-label, multicenter trial comparing BRAF inhibitor vemurafenib (vem) with dacarbazine (DTIC) in previously untreated patients with BRAFV600E-mutated melanoma. J Clin Oncol 30: Abstract 8502.
12. Chiarion Sileni V, Nortilli R, Aversa SM, Paccagnella A, Medici M, Corti L, Favaretto AG, Cetto GL, Monfardini S (2001) Phase II randomized study of dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine alone in advanced melanoma patients. Melanoma Res 11: 189-196.
13. Ciruelos EM, Twelves C, Dominguez MJ, Mckay H, Anthony A, Castellanos D, Bezares S, Ruiz A, Lopez-Lazaro L, Jimeno J, Celli C, Cortes-Funes H, Paz-Ares L (2002) Phase I clinical and pharmacokinetic study of the marine compound Aplidin (APL) administered as a 3 hour infusion every 2 weeks. Proc Am Soc Clin Oncol 21: Abstract 422.
14. Cuadrado A, Garcia-Fernandez LF, Gonzalez L, Suarez Y, Losada A, Alcaide V, Martinez T, Fernandez-Sousa JM, Sanchez-Puelles JM, Munoz A (2003) Aplidin induces apoptosis in human cancer cells via glutathione depletion and sustained activation of the epidermal growth factor receptor, Src, JNK, and p38 MAPK. J Biol Chem 278: 241-250.
15. Eggermont AM, Kirkwood JM (2004) Re-evaluating the role of dacarbazine in metastatic melanoma: What have we learned in 30 years? Eur J Cancer 40: 1825-1836.
16. Eisen T, Thomas J, Miller Jr. WH, Gore M, Wolter P, Kavan P, Martin JA, Lardelli P (2009) Phase II study of biweekly plitidepsin as second-line therapy in patients with advanced malignant melanoma. Melanoma Res 19: 185-192.
17. Faivre S, Chieze S, Delbaldo C, Ady-Vago N, Guzman C, Lopez-Lazaro L, Lozahic S, Jimeno J, Pico F, Armand JP, Martin JA, Raymond E (2005) Phase I and pharmacokinetic study of aplidine, a new marine cyclodepsipeptide in patients with advanced malignancies. J Clin Oncol 23: 7780-7782.
18. Falkson CI, Ibrahim J, Kirkwood JM, Coates AS, Atkins MB, Blum RH (1998) Phase III trial of dacarbazine versus dacarbazine with interferon alpha-2b versus dacarbazine with tamoxifen versus dacarbazine with interferon alpha-2b and tamoxifen in patients with metastatic malignant melanoma: An Eastern Cooperative Oncology Group study. J Clin Oncol 16: 1743-1751.
19. Ferme C, Mateos MV, Szyldergemajn S, Zucca E, Espinoza J, Briones J, Morschhauser F, Gisselbrecht C, Ribrag V (2008) Plitidepsin is active in peripheral T-cell lymphoma (PTCL): A subset analysis from an ongoing multicenter phase II trial. Blood 112: Abstract 1566.
20. Gomez-Roca C, Besse-Hammer T, Szyldergemajn S, Bahleda R, Diaz M, Vandermeeren A, Extremera S, Kahatt C, Soria JC, Awada A (2010) Phase IB study of plitidepsin (APL) with bevacizumab (BEV) in refractory solid tumor patients (pts). Eur J Cancer 8: Abstract 432.
21. Izquierdo MA, Bowman A, Garcia M, Jodrell D, Martinez M, Pardo B, Gomez J, Lopez-Martin JA, Jimeno J, Germa JR, Smyth JF (2008) Phase I clinical and pharmacokinetic study of plitidepsin as a 1-hour weekly intravenous infusion in patients with advanced solid tumors. Clin Cancer Res 14: 3105-3112.
22. Jelic S, Babovic N, Kovcin V, Milicevic N, Milanovic N, Popov I, Radosavljevic D (2002) Comparison of the efficacy of two different dosage dacarbazinebased regimens and two regimens without dacarbazine in metastatic melanoma: A single-centre randomized four-arm study. Melanoma Res 12: 91-98.
23. Jungnelius U, Ringborg U, Aamdal S, Mattsson J, Stierner U, Ingvar C, Malmstrom P, Andersson R, Karlsson M, Willman K, Wist E, Bjelkengren G, Westberg R (1998) Dacarbazine-vindesine versus dacarbazine-vindesine-cisplatin in disseminated malignant melanoma. A randomised phase III trial. Eur J Cancer 34: 1368-1374.
24. Lev DC, Onn A, Melinkova VO, Miller C, Stone V, Ruiz M, McGary EC, Ananthaswamy HN, Price JE, Bar-Eli M (2004) Exposure of melanoma cells to dacarbazine results in enhanced tumor growth and metastasis in vivo. J Clin Oncol 22: 2092-2100.
25. Lev DC, Ruiz M, Mills L, McGary EC, Price JE, Bar-Eli M (2003) Dacarbazine causes transcriptional up-regulation of interleukin 8 and vascular endothelial growth factor in melanoma cells: A possible escape mechanism from chemotherapy. Mol Cancer Ther 2: 753-763.
26. Maroun JA, Belanger K, Seymour L, Matthews S, Roach J, Dionne J, Soulieres D, Stewart D, Goel R, Charpentier D, Goss G, Tomiak E, Yau J, Jimeno J, Chiritescu G (2006) Phase I study of Aplidine in a dailyx5 one-hour infusion every 3 weeks in patients with solid tumors refractory to standard therapy. A National Cancer Institute of Canada Clinical Trials Group study: NCIC CTG IND 115. Ann Oncol 17: 1371-1378.
27. Moneo MV, Serelde BG, Leal JFM, Blanco-Aparicio C, Diaz-Uriarte R, Aracil M, Tercero JC, Jimeno J, Carnero A (2007) Levels of p27kip1 determine Aplidins sensitivity. Mol Cancer Therapeut 6: 1310-1316.
28. Mouawad R, Sebert M, Michels J, Bloch J, Spano JP, Khayat D (2010) Treatment for metastatic malignant melanoma: Old drugs and new strategies. Crit Rev Oncol Hematol 74: 27-39.
29. Munoz-Alonso MJ, Alvarez E, Guillen-Navarro MJ, Pollan M, Aviles P, Galmarini CM, Munoz A (2013) c-Jun N-terminal kinase phosphorylation is a biomarker of plitidepsin activity. Mar Drugs 11: 1677-1692.
30. Munoz-Alonso MJ, Gonzalez-Santiago L, Martinez T, Losada A, Galmarini CM, Munoz A (2009) The mechanism of action of plitidepsin. Curr Opin Investig Drugs 10: 536-542.
31. Munzone E, Testori A, Minchella I, Mosconi M, Passoni C, Verri E, Cossu Rocca M, Lambiase A, Goldhirsch A, Nolè F (2007) A phase II trial of dacarbazine (DTIC) and bevacizumab in patients with metastatic melanoma. J Clin Oncol 25: Abstract 8579.
32. Neuman HB, Patel A, Ishill N, Hanlon C, Brady MS, Halpern AC, Houghton A, Coit DG (2008) A single-institution validation of the AJCC staging system for stage IV melanoma. Ann Surg Oncol 15: 2034-2041.
33. Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A (2011) Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: Final results of a randomised phase III study (EORTC 18032). Eur J Cancer 47: 1476-1483.
34. Robert C, Thomas L, Bondarenko I, O'Day S, M D JW, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller Jr WH, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD (2011) Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 364: 2517-2526.
35. Schadendorf D, Ugurel S, Schuler-Thurner B, Nestle FO, Enk A, Brocker EB, Grabbe S, Rittgen W, Edler L, Sucker A, Zimpfer-Rechner C, Berger T, Kamarashev J, Burg G, Jonuleit H, Tuttenberg A, Becker JC, Keikavoussi P, Kampgen E, Schuler G (2006) Dacarbazine (DTIC) versus vaccination with autologous peptide-pulsed dendritic cells (DC) in first-line treatment of patients with metastatic melanoma: A randomized phase III trial of the DC study group of the DeCOG. Ann Oncol 17: 563-570.
36. Stein MN, Ribrag V, Gomez-Roca CA, Salles GA, Carella AM, Gyan E, Szyldergemajn SA, Kahatt CM, Luque M, Extremera S, De Miguel B, Fernandez-Garcia E, Soria JC (2012) Phase Ib study of plitidepsin (APL) with gemcitabine (GEM) in refractory solid tumors and lymphoma patients. J Clin Oncol 30: Abstract 2539.
37. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92: 205-216.