NCT00749723

Therapy Optimization Trial for the Treatment of Relapsed or Refractory Brain Tumors in Children

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: All
• Age: 3 Months – 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Recurrent Brain Tumors
• Supratentorial PNETs
• Medulloblastomas
• Ependymomas

Interventions

Type	Name	Description
DRUG	carboplatin	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
DRUG	etoposide	100mg/m²/d continuously IV on day 1-4 of each 21-28 day cycle. Number of cycles: until disease progression, maximum 4 cycles
DRUG	temozolomide	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
DRUG	thiotepa, carboplatin, etoposide	high dose chemotherapy followed by to autologous stem cell transplantation
DRUG	temozolomide, thiotepa	high dose chemotherapy followed by autologous stem cell transplantation
PROCEDURE	autologous stem cell transplantation	autologous stem cell transplantation following HD-chemotherapy
DRUG	intraventricular etoposide	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
DRUG	trofosfamide, etoposide	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

Timeline

• Start date: 2006-02-01
• Primary completion: 2015-01-31
• Completion: 2016-01-31
• First posted: 2008-09-09
• Last updated: 2018-07-20

Locations

54 sites across 1 country: Germany