Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ependymomas | Ependymoma | ALIAS | 0.90 |
| Medulloblastomas | Medulloblastoma | ALIAS | 0.90 |
| Recurrent Brain Tumors | Brain Neoplasm | CURATED_BROADER | 0.78 |
| Supratentorial PNETs | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous stem cell transplantation | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| intraventricular etoposide | Drug | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
| temozolomide, thiotepa | Drug | — | UNRESOLVED |
| thiotepa, carboplatin, etoposide | Drug | — | UNRESOLVED |
| trofosfamide, etoposide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1: P-HIT-REZ 2005
- description
- intravenous chemotherapy with carboplatin/etoposide,followed by * high dose chemotherapy with thiotepa, carboplatin, etoposide and autologous stem cell transplantation if patient have achieved a complete remission or * maintenance therapy with oral trofosfamide, etoposide
- interventionNames
- Drug: carboplatin
- Drug: etoposide
- Drug: thiotepa, carboplatin, etoposide
- Procedure: autologous stem cell transplantation
- Drug: intraventricular etoposide
- Drug: trofosfamide, etoposide
- type
- EXPERIMENTAL
- label
- 2: P-HIT-REZ 2005
- description
- oral chemotherapy with temozolomide, followed by * high dose chemotherapy with temozolomide, thiotepa and autologous stem cell transplantation if patient have achieved a complete remission * maintenance therapy with oral temozolomide or in case of progression with oral trofosfamide, etoposide
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available