Therapy-Optimization Trial and Phase II Study for the Treatment of Relapsed or Refractory of Primitive Neuroectodermal Brain Tumors and Ependymomas in Children and Adolescents
Parts of the study:
P-HIT-REZ-2005: a trial for the treatment of relapsed PNETs
(medulloblastomas,supratentorial PNETs)
E-HIT-REZ-2005: a trial for the treatment of relapsed ependymomas (Phase II-Study with
temozolomide)
Phase II-Study: intraventricular therapy with etoposide in neoplastic meningitis in relapsed
PNETs and ependymomas with subarachnoid tumor manifestation (window study)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
P-HIT-REZ 2005 study: two Chemotherapy-arms: progression-free survival from therapy start and response evaluation after the fourth therapy course
10 years
No
Gudrun Fleischhack, MD
Principal Investigator
Department of Pediatric Hematology & Oncology, Pediatrics III, University Children's Hospital Essen
Germany: Federal Institute for Drugs and Medical Devices
EUDRACT 2005-002618-40
NCT00749723
February 2006
January 2016
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