Therapy Optimization Trial for the Treatment of Relapsed or Refractory Brain Tumors in Children
Condition: Recurrent Brain Tumors; Supratentorial PNETs; Medulloblastomas; Ependymomas
MeSH terms: Brain Neoplasms; Ependymoma; Medulloblastoma
Study type: Interventional
Phase: Phase 2/Phase 3

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)
    

Intervention name(s): carboplatin; etoposide; temozolomide; thiotepa, carboplatin, etoposide; temozolomide, thiotepa; autologous stem cell transplantation; intraventricular etoposide; trofosfamide, etoposide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Carboplatin IV; etoposide IV; temozolomide orally; thiotepa, carboplatin, etoposide IV, high dose; temozolomide, thiotepa IV; ASCT; etoposide intra-CSF; trofosfamide, etoposide orally
Intervention MeSH terms: Carboplatin; Etoposide; Etoposide phosphate; Temozolomide; Thiotepa; Trofosfamide; Cyclophosphamide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain tumor; relapse; children; etoposide; intraventricular; temozolomide