P-HIT-REZ 2005 study: Refractory and relapsed primitive neuroectodermal brain tumours (medulloblastomas, supratentorial PNETs) E-HIT-REZ 2005 study (Phase II Study "Oral therapy with temozolomide"): Refractory and relapsed ependymomas (WHO° II and III) Phase II Study “Intraventricular therapy with etoposide”: Refractory and relapsed primitive neuroectodermal brain tumours (medulloblastomas, supratentorial PNETs) and ependymomas (WHO° II and III) with neoplastic meningitis MedDRA version: 15.
Conditions
Interventions
Trade Name: ETO-GRY
Product Name: Etoposide
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Etoposide
CAS Number: 33419-42-0
Other descriptive name: Etoposide
Concentra
Sponsors
Rheinische Friedrich-Wilhelms-University of Bonn, University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All arms in P-HIT-REZ 2005 and E-HIT-REZ 2005 studies: histologically proven medulloblastoma, supratentorial PNET or pineoblastoma (P-HIT-REZ 2005 study) or ependymoma (WHO°II or III) (E-HIT-REZ 2005 study); refractory or relapsed disease; age = 3 months up to = 30 years; MRT of the brain and spinal canal and lumbal and/or ventricular CSF evaluation for tumour cells within the last 2 weeks before study entry; radiologically measurable disease in the MRT and/or detection of tumour cells in the CSF; no other systemic or local antineoplastic therapy within the last 2 weeks before study entry or during study treatment; women of childbearing potential needs a negative pregnancy test before and adequate contraception during the study participation; no nursing women reachability of the patient during the study treatment; written informed consent by the treating hospital and by the patient, the parents or care holders High dose chemotherapy in P-HIT-REZ 2005 study: 1st relapse of a supra- or infratentorial PNET or multiple relapse without chemotherapy in pretreament; complete remission after 4 courses of conventional chemotherapy or after partial response to chemotherapy and complete tumour resection; adequate autologous stem cell collection Phase II study “Intraventricular therapy with etoposide”: histologically proven medulloblastoma, supratentorial PNET or pineoblastoma or ependymoma with proven subarachnoidal metastatic disease and/or neoplastic meningitis; age =3 months up to =30 years, MRT of the brain and spinal canal, DTPA-CSF-flow-scintigraphy and lumbal and/or ventricular CSF evaluation for tumour cells within the last 2 weeks before study entry; radiologically measurable disease in the MRT and/or detection of tumour cells in the CSF; no threatening neurological symptoms due to a parenchymatous tumour manifestation; Ommaya-/Rickham reservoir or permanent lockable VP-/VA-shunt with a reservoir, no hydrocephalus occlusus or malresorptivus, undisturbed CSF flow and CSF resorption, no increased brain pressure (CSF pressure =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All arms in P-HIT-REZ 2005 and E-HIT-REZ 2005 studies: Participation in this trial previously; Other preexistent severe disease which could impair the realisation of study treatment; Absence of or incomplete written informed consent. High dose chemotherapy in P-HIT-REZ 2005 study: Refractory disease to primary treatment of a newly diagnosed brain tumour; High dose chemotherapy with autologous stem cell transplantation during the primary treatment or other previous stem cell or organ transplantation. Phase II study “Intraventricular therapy with etoposide” Exclusively tumour manifestation in the cerebral or cerebellar parenchyma Other tumour histology than PNETs or ependymoma Necessity of a permanent VP- or VA-shunt Other preexistent severe disease which could impair the realisation of study treatment Absence of or incomplete written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: P-HIT-REZ 2005 study: Following the 2nd amendment of this study the recruitment of patients in both chemotherapy-arms (iv: carboplatin/etoposide; oral: temozolomide) and documentation-arm will be ongoing without randomisation. Due to these changes the primary end point of the study, the progression-free survival after randomisation, can not be evaluated. Explorative analysis of PFS will be performed as secondary endpoints. E-HIT-REZ 2005 study (Phase II Study "Oral chemotherapy with temozolomide"): Evaluation of response rate (response rate: CR+PR+SD/N) to the 60-days oral chemotherapy with temozolomide (CR complete remission, PR partial remission, SD stable disease, N number of enrolled patients). Phase II study “Intraventricular therapy with etoposide”: Evaluation of response rate (response rate: CR+PR+SD/N) to the 5-week intraventricular therapy with etoposide (CR complete remission, PR partial remission, SD stable disease, N number of enrolled patients). ;Timepoint(s) of evaluation of this end point: P-HIT-REZ 2005 study: 2016/01/31 E-HIT-REZ 2005 study: 2016/01/31 Phase II study “Intraventricular therapy with etoposide”: 2013/03/31;Secondary Objective: P-HIT-REZ 2005 study: Explorative analysis: Chemotherapy-arms: progressionfree survival (PFS) from start of therapy (PFSTS), OS from start of therapy (OSTS), PFS from response after the 4th chemotherapy course (PFSRESP), OS from response after the 4th chemotherapy course (OSRESP), toxicity rate (CTC), historical comparison with the HIT-REZ 97-Study (PFSRESP, OSRESP), multivariable Cox-regression of prognostic parameters for OS/PFS; Documentation-arm: number, response, toxicity rate of other therapies. E-HIT-REZ 2005 study: Chemotherapy-arm: PFS from start of chemotherapy (PFSTSCHT), OS from start of chemotherapy (OSTSCHT), PFS from response (PFSRESP), OS from response (OSRESP), toxicity rate (CTC), historical comparison with the HIT-REZ 97-Study (PFSRESP, OSRESP); Documentation-arm: number | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): P-HIT-REZ 2005 study: Explorative analysis: Chemotherapy-arms: progressionfree survival (PFS) from start of therapy (PFSTS), OS from start of therapy (OSTS), PFS from response after the 4th chemotherapy course (PFSRESP), OS from response after the 4th chemotherapy course (OSRESP), toxicity rate (CTC), historical comparison with the HIT-REZ 97-Study (PFSRESP, OSRESP), multivariable Cox-regression of prognostic parameters for OS/PFS; Documentation-arm: number, response, toxicity rate of other therapies. E-HIT-REZ 2005 study: Chemotherapy-arm: PFS from start of chemotherapy (PFSTSCHT), OS from start of chemotherapy (OSTSCHT), PFS from response (PFSRESP), OS from response (OSRESP), toxicity rate (CTC), historical comparison with the HIT-REZ 97-Study (PFSRESP, OSRESP); Documentation-arm: number, response, toxicity rate of other therapies. Phase II study “Intraventricular therapy with etoposide”: Safety (administered doses/courses), toxicity rate (CTC) ;Timepoint(s) of evaluation of this end point: P-HIT-REZ 2005 study: 2016/01/31 E-HIT-REZ 2005 study: 2016/01/31 Phase II study “Intraventricular therapy with etoposide”: 2014/01/31 | — |
Countries
Germany
Contacts
Public ContactDept. of Ped. Hematology/Oncology
University Hospital Essen, Pediatrics III
Outcome results
None listed