Phase I trial of r viscumin (INN: aviscumine) given subcutaneously in patients with advanced cancer: A study of the European Organisation for Research and Treatment of Cancer (EORTC protocol number 13001)

Lothar Bergmann, Steiner Aamdal, Sandrine Marreaud, Denis Lacombe, Manfred Herold, Takuhiro Yamaguchi, Karin Wilhelm-Ogunbiyi, Hans Lentzen, Heinz Zwierzina

Research output: Contribution to journalArticlepeer-review

19 Citations (Scopus)

Abstract

Safety of aviscumine by subcutaneous route was assessed in patients with advanced cancer refractory to chemotherapy. Patients with progressive disease received escalating doses twice weekly. Treatment of the accrued 26 patients (10 colorectal cancer (CRC), 6 soft tissue sarcoma (STS), 5 melanoma (MM), 5 others) was well tolerated without substance-related grade 3 or 4 toxicities. Grade 1/2 toxicities were predominantly injection site reactions. Aviscumine lacked dose-limiting toxicity (DLT) up to a maximal dose of 10 ng/kg. An increase of interleukin-1β and interferon-γ from baseline was seen in the patient's plasma between the 1st and 11th injection. Highest release of both cytokines was in the dose range of 4-5.9 ng/kg. Interferon-γ was not detected after doses higher than 6 ng/kg. Eight patients (5 CRC, 1 MM, 1 STS, 1 RCC) had disease stabilisation for 79-250 days (median122 days) associated with an increase of interleukin (IL)-1β and interferon (IFN)-γ. Aviscumine was well tolerated and appeared to possess clinical activity at a biologically active dose between 4 and 6 ng/kg.

Original languageEnglish
Pages (from-to)1657-1662
Number of pages6
JournalEuropean Journal of Cancer
Volume44
Issue number12
DOIs
Publication statusPublished - 2008 Aug
Externally publishedYes

Keywords

  • Aviscumine
  • Phase I trial
  • Ribosome-inactivating protein
  • Solid tumours
  • rViscumin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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