[Criteria for clinical studies exemplified by immuno- and immunochemotherapy of renal cell carcinoma].
Clinical trials of phase I to III are the basis of testing drugs before their wide use among patients. In order to provide high quality treatment in oncology, particularly in palliative care of tumour patients, it is of critical importance to pay attention both to study characteristics and to the relevant German laws for clinical drug testing. For more than 20 years interleucin-2 and interferon-alpha based immunotherapy of metastatic renal cell carcinoma has been in controversy. In spite of various clinical protocols no consensus concerning the value of these concepts has been reached. Therefore, high quality oncological studies are necessary to determine the effectiveness of this type of immunotherapy and to avoid an uncritical application of a toxic and expensive treatment.
Steiner
T
T
Klinik und Poliklinik für Urologie, Friedrich-Schiller-Universität Jena. steiner@landgraf.med.uni-jena.de
Berg
W
W
Schubert
J
J
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003131:Combined Modality Therapy; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000627:therapeutic use*
D016898:Interferon-alpha; D007376:Interleukin-2