Longterminfusion Study (LTI)
Author: Prof. Dr. med. Holger Lode, Julia Dobke, erstellt am: 2012/04/11, Last modification: 2012/06/13
Longterminfusion Study (LTI) | A Phase I/II Dose Schedule Finding Study of ch14.18/CHO Continuous Infusion Combined with Subcutaneous Aldesleukin (=Proleukin) (IL-2) in Patients with Primary Refractory or Relapsed Neuroblastoma. A SIOPEN Study. |
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Disease | Primary refractory or relapsed Neuroblastoma |
Type | Prospective, non-blinded, open-label, dose schedule finding, multi-centre phase I/II study |
Problem / Objectives |
The immunotherapy of neuroblastoma with ch14.18 antibody is an effective therapeutical option, with severe pain from neuropathia as an main side effect.
Primary endpoint: |
Therapy / Study arms |
Immunotherapy with ch14.18 antibody as an 24 hrs longterminfusion over at leat 10 days; dayly dose 10 mg/m². |
Inclusion Criteria |
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Recruitment | Minimum N = 20 patients, Maximum N = 60 patients |
Status | Recruitment: 01.04.2012-31.03.2014 |
EudraCT | 2009-018077-31 |
Entry Study Register | |
Principal Investigator | Prof. Dr. med. H. Lode, Prof. Dr. med. R. Ladenstein |
Contact |
Principal investigatorsProf. Dr. Holger Lode Universitätsklinikum Greifswald Allg. Pädiatrie mit Poliklinik/Päd. Onkologie Ferdinand-Sauerbruch-Str. 17475 Greifswald Telefon +49 (3834) 86 6301 Fax +49 (3834) 86 6410 holger.lode@uni-greifswald.de Prof. Dr. med. Ruth Ladenstein St. Anna-Kinderspital Children´s Cancer Research Institute (CCRI) Kinderspitalgasse 6 1090 Wien Telefon +43 (1) 40470 4750 Fax +43 (1) 40470 7430 ruth.ladenstein@ccri.at |
Participants | University Children's Hospital, Greifswald, Germany St. Anna Children’s Hospital, Vienna, Austria Great Ormond Street, London, UK Gaslini Children’s Hospital, Genova, Italy Hospital Universitario La Fe, Valencia, Spain Institut Curie, Paris, France Institut Gustave Roussy, Villejuif, France Schneider Children’s Medical Centre of Israel, Petach Tikvah, Israel Sydney Children’s Hospital, Sydney, Australia |
Weitere Informationen | Funds: The antibody production was based on a national SIOPEN fundraising. The database and trial is supported by the SIOPEN association. Further financial support: Hector-Stiftung (Prof. Lode). |
Sponsoring | Sponsor: St. Anna Kinderkrebsforschung (international) Children’s Cancer Research Institute (CCRI) Zimmermannplatz 10, A-1090 Vienna, Austria Universitätsmedizin Greifswald (national) Fleischmannstrasse 8, 17475 Greifswald |