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)

Bergmann, Lothar;Aamdal, Steiner;Marreaud, Sandrine;Lacombe, Denis;Zwierzina, Heinz;et.al.
(2008) European Journal of Cancer — Vol. 44, n° 12, p. 1657-1662 (2008)

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Authors
  • Bergmann, Lothar
    Author
  • Aamdal, Steiner
    Author
  • Marreaud, SandrineUCLouvain
    Author
  • Lacombe, DenisUCLouvain
    Author
  • Yamayuchi, TakuhiroUCLouvain
    Author
  • Zwierzina, Heinz
    Author
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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-1 beta and interferon-gamma 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 45.9 ng/kg. Interferon-gamma 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)-1 beta and interferon (IFN)-gamma. Aviscumine was well tolerated and appeared to possess clinical activity at a biologically active dose between 4 and 6 ng/kg. (C) 2008 Elsevier Ltd. All rights reserved.
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Bergmann, L., Aamdal, S., Marreaud, S., Lacombe, D., Herold, M., Yamayuchi, T., Wilhelm-Ogunbiyi, K., Lentzen, H., & Zwierzina, H. (2008). 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). European Journal of Cancer, 44(12), 1657-1662. https://doi.org/10.1016/j.ejca.2008.05.005 (Original work published 2008)