The purpose of this study is to improve overall survival while maintaining a good quality of life in pediatric patients with refractory or recurrent brain tumors (medulloblastomas, supratentorial PNETs, ependymomas WHO grade II and III). Response to different chemotherapy options (intravenous versus oral chemotherapy, intraventricular chemotherapy) as part of a multimodal therapy will be assessed. Progression-free, overall survival and toxicity will be evaluated additionally.
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
200 mg/m²/d continuously IV on day 1-4 of each 21-28-day-cycle. Number of cycles: until disease progression, maximum 4 cycles
100mg/m²/d continuously IV on day 1-4 of each 21-28 day cycle. Number of cycles: until disease progression, maximum 4 cycles
150mg/m²/d p.o. on day 1-5 of a 21-28-day-cycle. Number of cycles: until progression or maximum up to 2 years
high dose chemotherapy followed by to autologous stem cell transplantation
high dose chemotherapy followed by autologous stem cell transplantation
autologous stem cell transplantation following HD-chemotherapy
prior to systemic chemotherapy as single agent in patients with neoplastic meningitis, in addition to systemic chemotherapy if proven effective in phase II study, intraventricularly age-dependent daily dose (\>3m to \<3y 0.7 mg; \>3y 1.0 mg) for 5 days every 2 two 4 weeks. Number of cycles: at least 3 courses, maximum up to 2 years
maintenance therapy: trofosfamide and etoposide: 100 mg/m²/d and 25 mg/m²/d, respectively, for 21 days every 4 weeks. Number of cycles: until progression or maximum up to 2 years
Universitätskinderklinik Aachen
Aachen, Germany
Klinikum Augsburg, Klinik für Kinder- und Jugendmedizin
Augsburg, Germany
Helios Klinikum Berlin-Buch, Klinik für Kinderheilkunde und Jugendmedizin
Berlin, Germany
Charité Klinikum Campus Virchow, Kinderklinik
Berlin, Germany
Klinik ür Kinder- und Jugendmedizin in Bethel
Bielefeld, Germany
P-HIT-REZ 2005 study: two Chemotherapy-arms: response evaluation after the fourth therapy course
determination of objective repsonse rate (CR+PR)
Time frame: 4 months for each patient (8 years for the whole study population)
E-HIT-REZ 2005 study (Phase II Study "Oral chemotherapy with temozolomide"): Evaluation of response rate to the 60-days oral chemotherapy with temozolomide
determination of objective repsonse rate (CR+PR/all patients)
Time frame: 2 months for each patient (8 years for the whole study population)
Phase II study "Intraventricular therapy with etoposide": Evaluation of response rate to the 5-week intraventricular therapy with etoposide
disease stabilization rate (CR+PR+SD/all patients)
Time frame: 6 weeks for each patient (8 years for the whole study population)
P-HIT-REZ 2005 study: two Chemotherapy-arms: PFS and OS from start of therapy
progression free and overall survival from start of therapy until PD, last follow up or death, respectively
Time frame: 10 years
P-HIT-REZ 2005 study: two Chemotherapy-arms: toxicity rate (CTC) in both arms
rate of adverse events of CTC°3 or CTC°4 according to CTCAE v3.0
Time frame: 8 years
E-HIT-REZ 2005 study: Chemotherapy-arm: PFS and OS from start of therapy
progression free and overall survival from start of therapy until PD, last follow up or death, respectively
Time frame: 10 years
E-HIT-REZ 2005 study: Chemotherapy-arm: toxicity rate (CTC)
progression free and overall survival from start of therapy until PD, last follow up or death, respectively
Time frame: 10 years
Phase II study "Intraventricular therapy with etoposide": toxicity rate (CTC)
rate of adverse events of CTC°1-4 according to CTCAE v3.0
Time frame: 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätskinderklinik Bonn
Bonn, Germany
Städtisches Klinikum Braunschweig, Kinderklinik
Braunschweig, Germany
Klinikum Bremen-Mitte
Bremen, Germany
Universitätskinderklinik Köln
Cologne, Germany
Carl-Thiele-Klinikum Cottbus, Zentrum für Kinderheilkunde
Cottbus, Germany
...and 44 more locations