Clinical trial · Interventional
Temozolomide and Radiation Therapy in Treating Young Patients With Pontine Glioma
A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas
- 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 temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.
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 and Central Nervous System Tumors | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| motexafin gadolinium | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall survival
- measure
- Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods
Secondary outcomes (2)
- measure
- Toxicity, steroid usage, and radiological response
- measure
- Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI * No requirement for histological diagnosis * Clinical history \< 6 months * Clinical findings must include at least 1 of the 3 following signs of brainstem tumor: * Cranial nerve deficit * Long tract signs * Ataxia Exclusion criteria: * Focal lesions of brainstem * Predominantly exophytic tumors PATIENT CHARACTERISTICS: Inclusion criteria: * Karnofsky performance status (PS) or Lansky PS 60-100% (unless reason for decrease in status is a direct result of neurological involvement of the brainstem glioma) * Life expectancy \> 12 weeks * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Urea and serum creatinine \< 1.5 times upper limit of normal (ULN) * Total and direct bilirubin \< 1.5 times ULN * AST and ALT \< 3 times ULN * Negative pregnancy test within 7 days prior to administration of temozolomide for women of childbearing potential Exclusion criteria: * Frequent vomiting and/or medical condition, that could interfere with oral medication intake (e.g., partial bowel obstruction) * Pregnant or breast-feeding women PRIOR CONCURRENT THERAPY: Exclusion criteria: * Prior chemotherapy or radiotherapy * Other concurrent investigational drugs * Other concurrent chemotherapy, immunotherapy, or biologic therapy
References
Publications (0)
Data not yet available