27
Participants
Start Date
December 31, 2008
Primary Completion Date
February 29, 2012
Study Completion Date
June 30, 2012
trabedersen
temozolomide
Drug delivery system for administration of AP 12009
Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).
Placement of Drug Delivery System
Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
carmustine
lomustine
Tri-Service General Hospital, Taipei
China Medical University Hospital, Taichung
Taichung Veterans General Hospital, Taichung
AKH Wien, Klinik für Neurochirurgie, Vienna
Universitätsklinik Innsbruck, Abteilung für Neurologie, Innsbruck
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged
Winthrop University Hospital, Mineola
La Timone University Hospital, Marseille
Medica Sur, Mexico City
University of Rochester Medical Center, Rochester
Universitätklinikum Hamburg-Eppendorf, Klinik für Neurochirurgie, Hamburg
Hospital Doce de Octubre, Madrid
Medizinische Hochschule Hannover Neurochirurgische Klinik, Hanover
Hospital Universitario Marqués de Valdecilla, Santander
Otto-von-Guericke-Universität, Klinik für Neurochirurgie, Magdeburg
Hospital Universitario Virgen del Rocío, Seville
Hospital San Javier, Guadalajara
Klinik und Poliklinik für Neurochirurgie, Münster
Hospital de Cruces, Barakaldo
Klinik und Poliklinik für Neurochirurgie, Frankfurt/M.
Universitätsklinik Heidelberg Neurologische Klinik, Heidelberg
Universitätsklinikum Freiburg, Freiburg im Breisgau
Neurochirurgische Klinik an der Universität Ulm am Bezirkskrankenhaus Günzburg, Günzburg
Klinik und Poliklinik für Neurologie, Regensburg
All India Institute of Medical Sciences (AIIMS), New Delhi
State Institution Russian Oncology Research Center N.N. Blokhin, Moscow
Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh
Russian Scientific Research Neurosurgical Institute A.L. Polenov, Saint Petersburg
Military Medical Academy, Neurosurgery Dept, Saint Petersburg
SGPGI of Medical Sciences, Lucknow
Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Mumbai
Samara Region Clinical Hospital M.I. Kalinin, Samara
Chelyabinsk City Hospital #3; Department of Neurosurgery, Chelyabinsk
Care Hospitals, Hyderabaad
Manipal Hospital & Manipal Institute for Neurological Disorders, Bangalore
Amrita Institute of Medical Sciences Research Center, Kochi
NIMHANS, Bangalore
BGS Global Hospital, Bangalore
Apollo Speciality Hospitals, Chennai
SCTIMST, Dept. of Neurosurgery, Thiruvananthapuram
AMRI Hospitals, Kolkata
NJ Neuroscience Institute; JFK Medical Center, Edison
Hospital Británico, Buenos Aires
FLENI, Buenos Aires
Sanatorio Allende, Córdoba
Hospital de Câncer de Barretos, Barretos / SP
Centro Goiano de Oncologia (CGO), Goiânia
Hospital Sao Vicente de Paulo, Passo Fundo
Hospital de Clínicas de Porto Alegre, Porto Alegre
Hospital Sao Lucas da PUCRS, Porto Alegre
Hospital do Servidor Público Estadual, São Paulo
ECOGENE-21 Centre d'études cliniques, Chicoutimi
Foothills Medical Centre, Calgary
Montreal Neurological Institute and Hospital, Montreal
Universitätsklinikum Leipzig, Neurochirurgische Klinik, Leipzig
Hospital General de Mexico, Mexico City
Wojskowy Szpital Kliniczny, Klinika Neurochirurgii, Bydgoszcz
Akademickie Centrum Kliniczne, Gdansk
SP ZOZ Uniwersytecki Szpital Kliniczny nr 1, Klinika Neurochirurgii, Lodz
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Neurochirurgii i Neurochirurgii Dziecięcej, Lublin
Kliniczny Oddzial Neurochirurgii SUM w Sosnowcu Wojewódzki Szpital Specjalistyczny nr 5, Sosnowiec
Centrum Onkologii - Instytut Im. Marii Sklodowskiej-Curie, Warsaw
Severance Hospital, Yonsei University College of Medicine, Seoul
Kangnam St. Mary's Hospital, Seoul
Asan Medical Center, Seoul
Hospital Universitario Vall d'Hebron, Barcelona
Edinburgh Centre for Neuro-Oncology, Western General Hospital, Edinburgh
The National Hospital for Neurology and Neurosurgery, London
Lead Sponsor
Isarna Therapeutics GmbH
INDUSTRY