A Phase 2/3 interventional study of carboplatin and etoposide in Recurrent Brain Tumors, Supratentorial PNETs and Medulloblastomas, sponsored by University Hospital, Bonn. Completed at 54 sites in Germany. Open to participants aged 3 Months to 30 Years. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by University Hospital, Bonn · Phase 2/3, Interventional, and Treatment
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)
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 174 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.
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Inclusion Criteria:
Disease Characteristics
Hematological:
Renal:
Hepatic:
Pulmonary:
Cardiovascular:
Other:
intravenous chemotherapy with carboplatin/etoposide,followed by * high dose chemotherapy with thiotepa, carboplatin, etoposide and autologous stem cell transplantation if patient have achieved a complete remission or * maintenance therapy with oral trofosfamide, etoposide
Drug: carboplatin · Drug: etoposide · Drug: thiotepa, carboplatin, etoposide · Procedure: autologous stem cell transplantation · Drug: intraventricular etoposide · Drug: trofosfamide, etoposide
oral chemotherapy with temozolomide, followed by * high dose chemotherapy with temozolomide, thiotepa and autologous stem cell transplantation if patient have achieved a complete remission * maintenance therapy with oral temozolomide or in case of progression with oral trofosfamide, etoposide
Drug: temozolomide · Drug: temozolomide, thiotepa · Procedure: autologous stem cell transplantation · Drug: intraventricular etoposide
Phase II: oral chemotherapy with temozolomide after progression oral trofosfamide, etoposide
Drug: temozolomide · Drug: intraventricular etoposide · Drug: trofosfamide, etoposide
Phase II, intraventricular chemotherapy with etoposide
Drug: intraventricular etoposide
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
Also known as: Carboplatin IV
100mg/m²/d continuously IV on day 1-4 of each 21-28 day cycle. Number of cycles: until disease progression, maximum 4 cycles
Also known as: etoposide IV
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
Also known as: temozolomide orally
high dose chemotherapy followed by to autologous stem cell transplantation
Also known as: thiotepa, carboplatin, etoposide IV, high dose
high dose chemotherapy followed by autologous stem cell transplantation
Also known as: temozolomide, thiotepa IV
autologous stem cell transplantation following HD-chemotherapy
Also known as: ASCT
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
Also known as: etoposide intra-CSF
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
Also known as: trofosfamide, etoposide orally
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 study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Bonn