Clinical trial · Interventional
Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children
Phase 2 Study of Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children
NCT02672241CI-TRIAL-00035313unknownPhase 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 purpose of this study is to evaluate the safety and efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumor in children.
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 |
|---|---|---|---|
| Childhood Brain Stem Neoplasm | Childhood Brain Stem Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radio-chemotherapy plus nimotuzumab
- description
- Radiotherapy: The total radiation dose is 52.2Gy (1.8Gy fractions). Chemotherapy: Nimotuzumab, given during radiotherapy, is administered via intravenous drip with a dosage of 150mg/m2, weekly, for 6 consecutive weeks. After radiotherapy and evaluation, disease progression-free patients will continue to receive Nimotuzumab treatment biweekly until disease relapse or progression. Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation therapy are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles.
- interventionNames
- Drug: Nimotuzumab
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- first analysis will occur 1 month after accrual of all patients
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be \>/= 3 and \</= 21 years of age. * Patients must have a newly diagnosed or progressive brain stem tumor. * If biopsy has been performed, patients with both high and low grade astrocytomas are eligible. * Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry. * Cervicomedullary junction tumors are ineligible. * Patients with a diagnosis of NF-1 are ineligible. * Patients must be registered within 6 weeks from diagnosis or recurrence. * Patients must have life expectancy \> 6 weeks. * Patients must have adequate hematologic and renal function: ANC \>1,000/ul, platelets\>100,000/ul and creatinine normal for age: \</= 0.7 mg/dl (age 3-10yrs.), \</= 1.0 mg/dl (11-12yrs.). and \</= 1.2 (13-21yrs.). * Written informed consent must be obtained according to institutional guidelines. Exclusion Criteria: * Cervicomedullary junction tumors are ineligible. * Patients with a diagnosis of NF-1 are ineligible. * Pregnant or nursing women are ineligible. * Patients must not start treatment until informed consent is given and the patient is registered.
References
Publications (0)
Data not yet available
No reference posted for this study.