Clinical trial · Interventional
High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas
A Phase III Randomized Trial for the Treatment of Pediatric High Grade Gliomas at First Recurrence With a Single High Dose Chemotherapy and Autologous Stem Cell Transplant Versus Three Courses of Intermediate Dose Chemotherapy With Peripheral Blood Stem Cell (PBSC) Support
- 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)
RATIONALE: Drugs used in chemotherapy, such as carboplatin, thiotepa, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Isotretinoin may be effective in preventing recurrence of glioma. It is not yet known which regimen of chemotherapy plus autologous stem cell transplantation with or without isotretinoin is more effective in treating recurrent high-grade glioma. PURPOSE: This randomized phase III trial is studying high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation to see how well it works compared to high-dose chemotherapy or intermediate-dose chemotherapy followed by autologous stem cell transplantation and isotretinoin in treating young patients with recurrent high-grade glioma.
Conditions
Conditions (2)
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 Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| isotretinoin | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I (high-dose chemotherapy and ASCR)
- description
- Patients receive high-dose chemotherapy comprising carboplatin IV over 4 hours on days -8 to -6; thiotepa IV over 3 hours and etoposide IV over 3 hours on days -5 to -3; and filgrastim (G-CSF) IV or SC once daily beginning on day 1 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 0.
- interventionNames
- Biological: filgrastim
- Drug: carboplatin
- Drug: etoposide
- Drug: isotretinoin
- Drug: thiotepa
- Procedure: autologous bone marrow transplantation
- Procedure: peripheral blood stem cell transplantation
- type
- EXPERIMENTAL
- label
- Arm II (intermediate-dose chemotherapy and ASCR)
- description
- Patients receive intermediate-dose chemotherapy comprising carboplatin IV over 4 hours and thiotepa IV over 3 hours on days 1-2 and G-CSF IV or SC once daily beginning on day 4 and continuing until blood counts recover. Autologous PBSC or bone marrow are reinfused on day 3. Treatment repeats every 28 days for a total of 3 courses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following high-grade gliomas: * Glioblastoma multiforme * Anaplastic astrocytoma * Gliosarcoma * Disease in first relapse * No primary brainstem or spinal cord gliomas * No secondary glioblastomas arising after prior treatment for a non-glial tumor * Prior local radiotherapy of 5,000-6,000 cGy required * Less than 1.5 cm of residual gadolinium-enhancing tumor in maximal cross-sectional diameter by MRI * No metastatic tumor by spinal MRI PATIENT CHARACTERISTICS: Age * Under 21 at diagnosis Performance status * Lansky 50-100% OR * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 500/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST or ALT \< 2.5 times ULN Renal * Glomerular filtration rate ≥ 60 mL/min AND/OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * Shortening fraction ≥ 27% by echocardiogram OR * Ejection fraction ≥ 50% by MUGA Pulmonary * No dyspnea at rest * No exercise intolerance * Pulse oximetry \> 94% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior chemotherapy * No prior thiotepa * No prior myeloablative chemotherapy Endocrine therapy * No concurrent corticosteroids Radiotherapy * See Disease Characteristics * More than 8 weeks since prior radiotherapy * No prior craniospinal radiotherapy Surgery * Not specified
References
Publications (0)
Data not yet available