Status:
COMPLETED
Therapy Optimization Trial for the Treatment of Relapsed or Refractory Brain Tumors in Children
Lead Sponsor:
University Hospital, Bonn
Conditions:
Recurrent Brain Tumors
Supratentorial PNETs
Eligibility:
All Genders
3-30 years
Phase:
PHASE2
PHASE3
Brief 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 PNET...
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-St...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Disease Characteristics
- Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma
- Refractory or relapsed disease
- Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid Patients characteristics
- Performance status ECOG ≥ 3 or Karnofsky Status ≥ 40%
- Life expectancy ≥ 8 weeks
- Hematological:
- Absolute leukocyte count ≥ 2.0 x 10\^9 /l
- Hemoglobin ≥ 10g/dl
- Platelet count ≥ 70 x 10\^9/l
- Renal:
- Creatinine no greater than 1.5 times UNL
- No overt renal disease
- Hepatic:
- Bilirubin less than 2.5 times UNL
- AST and ALT less than 5 times UNL
- No overt hepatic disease
- Pulmonary:
- No overt pulmonary disease
- Cardiovascular:
- No overt cardiovascular disease
- Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection Prior concurrent therapy
- More than 2 weeks since prior systemic chemotherapy
- More than 4 weeks since prior radiotherapy
- No other concurrent anticancer or experimental drugs Examinations required
- Examination of lumbar CSF
- Cranial and spinal MRI within 14 days prior to start of treatment
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2016
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00749723
Start Date
February 1 2006
End Date
January 31 2016
Last Update
July 20 2018
Active Locations (54)
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1
Universitätskinderklinik Aachen
Aachen, Germany, 52074
2
Klinikum Augsburg, Klinik für Kinder- und Jugendmedizin
Augsburg, Germany, 86156
3
Helios Klinikum Berlin-Buch, Klinik für Kinderheilkunde und Jugendmedizin
Berlin, Germany, 13125
4
Charité Klinikum Campus Virchow, Kinderklinik
Berlin, Germany, 13353