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

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.

Conditions

• Recurrent Brain Tumors
• Supratentorial PNETs
• Medulloblastomas
• Ependymomas

Interventions

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

Sponsors & Collaborators

• University Hospital, Bonn

  lead OTHER

Principal Investigators

• Gudrun Fleischhack, MD · Department of Pediatric Hematology & Oncology, Pediatrics III, University Children's Hospital Essen

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

3 Months

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-02-01

Primary Completion

2015-01-31

Completion

2016-01-31

Countries

• Germany

Study Locations