PMID- 25324973
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20141017
LR  - 20220409
IS  - 2051-1426 (Print)
IS  - 2051-1426 (Electronic)
IS  - 2051-1426 (Linking)
VI  - 2
DP  - 2014
TI  - Treatment of unresectable stage IV metastatic melanoma with aviscumine after 
      anti-neoplastic treatment failure: a phase II, multi-centre study.
PG  - 27
LID - 10.1186/s40425-014-0027-z [doi]
AB  - BACKGROUND: Aviscumine, a recombinant plant protein, is an immune modulator that 
      induces ribotoxic stress at the 28S ribosomal RNA subunit. In this way cytokine 
      release and T-cell responses are enhanced. This phase II trial was conducted to 
      test the efficacy and safety of aviscumine in patients with systemically 
      pre-treated metastatic melanoma stage IV. METHODS: A total of 32 patients with 
      progressive stage IV melanoma after failure of standard therapy were enrolled 
      onto a single-arm, multi-centre, open-label, phase II trial. All patients had an 
      ECOG performance status of 0 or 1. Patients received 350 ng aviscumine twice 
      weekly by subcutaneous injection until progression. The primary end points were 
      progression-free survival (PFS) and overall survival (OS). Safety was assessed as 
      adverse events (AEs). Tumor response was assessed every eight weeks and survival 
      of patients was followed up to one year after the end of therapy. Thirty one 
      patients (intent-to-treat population (ITT)) were assessed for efficacy; safety 
      was assessed in the whole population. RESULTS: One patient achieved a partial 
      response (PR) and 10 patients showed stable disease/no change (SD). The median 
      progression-free survival (mPFS) was 63 days (95% CI 57-85) and median overall 
      survival (mOS) was 335 days (95% CI 210-604). In total 210 treatment-emergent 
      adverse events were recorded. Grade 1 or 2 AEs occurred in 72% of patients and 
      were mostly application-site effects such as pruritus Grade 3-4 
      treatment-emergent drug-related adverse events occurred in 9% of patients. 
      CONCLUSION: These results suggest that aviscumine may have a clinical impact in 
      patients with previously treated metastatic melanoma and provide rationale for 
      further clinical evaluation of this agent. In the light of effective new immune 
      checkpoint blockers it might be a candidate for combinations with these agents. 
      TRIAL REGISTRATION: ClinicalTrials.gov: NCT00658437.
FAU - Trefzer, Uwe
AU  - Trefzer U
AD  - Dermatologikum Berlin, Berlin, Germany.
FAU - Gutzmer, Ralf
AU  - Gutzmer R
AD  - Klinik fur Dermatologie, Allergologie und Venerologie, Hauttumorzentrum Hannover 
      (HTZH), Hannover, Germany.
FAU - Wilhelm, Tabea
AU  - Wilhelm T
AD  - Charite- Universitatsmedizin Berlin, Hauttumorcentrum Charite (HTCC), Klinik fur 
      Dermatologie, Venerologie und Allergologie, Berlin, Germany.
FAU - Schenck, Florian
AU  - Schenck F
AD  - Hautarzte Zentrum Hannover, Hannover, Germany.
FAU - Kahler, Katharina C
AU  - Kahler KC
AD  - Klinik fur Dermatologie, Venerologie und Allergologie, Universitatsklinikum 
      Schleswig-Holstein -Campus Kiel-, Kiel, Germany.
FAU - Jacobi, Volkmar
AU  - Jacobi V
AD  - Institut fur Diagnostische Radiologie, Klinikum der 
      Johann-Wolfgang-Goethe-Universitat, Frankfurt/Main, Germany.
FAU - Witthohn, Klaus
AU  - Witthohn K
AD  - MELEMA Pharma GmbH, Hamburg, Germany.
FAU - Lentzen, Hans
AU  - Lentzen H
AD  - MELEMA Pharma GmbH, Hamburg, Germany.
FAU - Mohr, Peter
AU  - Mohr P
AD  - Elbe-Klinikum Buxtehude, Dermatologisches Zentrum, Buxtehude, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT00658437
PT  - Journal Article
DEP - 20140819
PL  - England
TA  - J Immunother Cancer
JT  - Journal for immunotherapy of cancer
JID - 101620585
PMC - PMC4198912
OTO - NOTNLM
OT  - Aviscumine
OT  - CY-503
OT  - Cancer immunotherapy
OT  - Metastatic melanoma stage IV
OT  - Phase II trial
OT  - Ribosome-inactivating protein
EDAT- 2014/10/18 06:00
MHDA- 2014/10/18 06:01
PMCR- 2014/08/19
CRDT- 2014/10/18 06:00
PHST- 2014/03/27 00:00 [received]
PHST- 2014/07/16 00:00 [accepted]
PHST- 2014/10/18 06:00 [entrez]
PHST- 2014/10/18 06:00 [pubmed]
PHST- 2014/10/18 06:01 [medline]
PHST- 2014/08/19 00:00 [pmc-release]
AID - s40425-014-0027-z [pii]
AID - 10.1186/s40425-014-0027-z [doi]
PST - epublish
SO  - J Immunother Cancer. 2014 Aug 19;2:27. doi: 10.1186/s40425-014-0027-z. 
      eCollection 2014.