Clinical trial · Interventional
Tandem High Dose Chemotherapy and Autologous Stem Cell Rescue for High Risk Pediatric Brain Tumors
NCT01342237CI-TRIAL-00012668unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 investigators plan to improve event free survival rate and reduce treatment related toxicities of pediatric patients with high risk/recurrent CNS tumors by administrating tandem high dose chemotherapy and autologous stem cell rescue.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HDCT 1(TTC), HDCT2(MEC) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- topotecan
- interventionNames
- Drug: HDCT 1(TTC), HDCT2(MEC)
Primary outcomes (1)
- measure
- To evaluate event free survival rate
- timeFrame
- 1 month
- description
- To evaluate event free survival rate after high dose chemotherapy and autologous stem cell rescue in pediatric patients with high risk brain tumor
Secondary outcomes (3)
- measure
- To evaluate treatment related mortality
- timeFrame
- 1, 3, 6, 12 month
- measure
- To evaluate the incidence and severity of toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. High risk pediatric brain tumors Newly diagnosed medulloblastoma, CNS PNET, ATRT, Choroid plexus carcinoma, pineoblastoma with residual tumor over 1.5cm2 after operation or with leptomeningeal seeding at diagnosis 2. All high grade or malignant brain tumor, age \< 3 years 3. Recurrent embryonal brain tumors, recurrent CNS germ cell tumor 4. Age : no limitation 5. Performance status : ECOG 0-2. 6. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. Heart: a shortening fraction ≥ 28%. Liver: total bilirubin \< 2 ⅹ upper limit of normal; ALT \< 3 ⅹ upper limit of normal. Kidney: creatinine \< 2 ⅹ normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2. 7. Patients must lack any active viral infections or active fungal infection. 8. Patients (or one of parents if patients age \< 20) should sign informed. Exclusion Criteria: 1. Patients who do not reach partial response prior to high dose chemotherapy. 2. Pregnant or nursing women. 3. Malignant (except brain tumor) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 4. Psychiatric disorder that would preclude compliance. 5. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.