<oai_dc:dc xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:oai_dc="http://www.openarchives.org/OAI/2.0/oai_dc/" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.openarchives.org/OAI/2.0/oai_dc/ http://www.openarchives.org/OAI/2.0/oai_dc.xsd">
  <dc:creator>Dummer R</dc:creator>
  <dc:creator>Rochlitz C</dc:creator>
  <dc:creator>Velu T</dc:creator>
  <dc:creator>Acres B</dc:creator>
  <dc:creator>Limacher JM</dc:creator>
  <dc:creator>Bleuzen P</dc:creator>
  <dc:creator>Lacoste G</dc:creator>
  <dc:creator>Slos P</dc:creator>
  <dc:creator>Romero P</dc:creator>
  <dc:creator>Urosevic M</dc:creator>
  <dc:date>2008</dc:date>
  <dc:description xmlns:ns0="xml" ns0:lang="en">Numerous preclinical and clinical studies have shown that interleukin-2 (IL-2) induces regression of metastatic tumors. We have conducted a phase I/II, multicenter, open-label, dose-escalating study to evaluate the safety, efficacy, and biological effects of repeated intratumoral injections of adenovirus-IL-2 (TG1024) in patients with advanced solid tumors and melanoma. Thirty five patients (twenty-five with metastatic melanoma and ten with other solid tumors) were treated in eight successive cohorts at dose levels ranging from 3 x 10(8) to 3 x 10(11) viral particles (vp). Intratumoral TG1024 injections in combination with dacarbazine (DTIC) were tested in metastatic melanoma in one cohort. No clinical responses were observed at doses below 3 x 10(11) vp. Six local objective responses were recorded in patients receiving 3 x 10(11) vp per treatment [five in metastatic melanoma and one in metastatic squamous cell carcinoma (SCC) of the skin], of which two were complete responses (CRs). Most of the common side effects were injection site reactions and flu-like syndrome. TG1024 dose intensification across cohorts resulted in increased serum IL-2 levels after the injection. Intratumoral TG1024 injection induced pronounced inflammation of the treated lesion, with predominant CD8(+), TIA+ lymphocytic infiltrate. Our results show that intratumoral injections of TG1024 are safe and well tolerated. The clinical activity of TG1024 observed in this study warrants further investigations.</dc:description>
  <dc:identifier>https://sonar.ch/global/documents/4394</dc:identifier>
  <dc:language>eng</dc:language>
  <dc:relation>info:eu-repo/semantics/altIdentifier/doi/10.1038/mt.2008.32</dc:relation>
  <dc:relation>info:eu-repo/semantics/altIdentifier/pmid/18388930</dc:relation>
  <dc:source>Molecular therapy : the journal of the American Society of Gene Therapy. - 2008</dc:source>
  <dc:subject xmlns:ns1="xml" ns1:lang="en">Adenoviridae</dc:subject>
  <dc:subject xmlns:ns2="xml" ns2:lang="en">Adult</dc:subject>
  <dc:subject xmlns:ns3="xml" ns3:lang="en">Aged</dc:subject>
  <dc:subject xmlns:ns4="xml" ns4:lang="en">Aged, 80 and over</dc:subject>
  <dc:subject xmlns:ns5="xml" ns5:lang="en">Carcinoma, Squamous Cell</dc:subject>
  <dc:subject xmlns:ns6="xml" ns6:lang="en">Dacarbazine</dc:subject>
  <dc:subject xmlns:ns7="xml" ns7:lang="en">Female</dc:subject>
  <dc:subject xmlns:ns8="xml" ns8:lang="en">Gene Transfer Techniques</dc:subject>
  <dc:subject xmlns:ns9="xml" ns9:lang="en">Genetic Therapy</dc:subject>
  <dc:subject xmlns:ns10="xml" ns10:lang="en">Genetic Vectors</dc:subject>
  <dc:subject xmlns:ns11="xml" ns11:lang="en">Humans</dc:subject>
  <dc:subject xmlns:ns12="xml" ns12:lang="en">Interleukin-2</dc:subject>
  <dc:subject xmlns:ns13="xml" ns13:lang="en">Male</dc:subject>
  <dc:subject xmlns:ns14="xml" ns14:lang="en">Melanoma</dc:subject>
  <dc:subject xmlns:ns15="xml" ns15:lang="en">Middle Aged</dc:subject>
  <dc:subject xmlns:ns16="xml" ns16:lang="en">Neoplasm Metastasis</dc:subject>
  <dc:title xmlns:ns17="xml" ns17:lang="en">Intralesional adenovirus-mediated interleukin-2 gene transfer for advanced solid cancers and melanoma.</dc:title>
  <dc:type>http://purl.org/coar/resource_type/c_6501</dc:type>
</oai_dc:dc>