Clinical trial · Interventional
Vandetanib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Diffuse Brainstem Glioma
Phase I Trial of Vandetanib (ZD6474, ZACTIMA) With Concurrent Radiation in Treatment of Newly Diagnosed Brainstem Glioma
NCT00472017CI-TRIAL-00008263completedPhase 1ClinicalTrials.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)
This phase I trial is studying the side effects and best dose of vandetanib when given together with radiation therapy in treating young patients with newly diagnosed diffuse brain stem 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vandetanib | Drug | Vandetanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pediatric Diffuse Brainstem Glioma Patients
- description
- Patients with newly diagnosed diffuse brainstem gliomas receive vandetanib.
- interventionNames
- Drug: vandetanib
Primary outcomes (1)
- measure
- To estimate the maximum tolerated dose (MTD) and to determine the dose-limiting toxicity (DLT) of vandetanib administered concurrently with radiation therapy (RT) in pediatric patients with newly diagnosed diffuse brainstem glioma.
- timeFrame
- 3 Years
Secondary outcomes (6)
- measure
- To determine the toxicities associated with the chronic use of vandetanib in pediatric patients
- timeFrame
- 3 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
* Diagnosis of 1 of the following: * Diffuse brainstem glioma * High-grade glioma originating from brainstem * Age must be greater than or equal to 2 years and less than 21 years * Newly diagnosed disease * Lansky OR Karnofsky performance status 40-100% * ANC ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ (transfusion independent) * Hemoglobin ≥ 8 g/dL (transfusion allowed) * Bilirubin \< 1.5 times upper limit of normal (ULN) for age * ALT \< 5 times ULN * Albumin ≥ 2 g/dL * Creatinine \< 2 times ULN for age OR glomerular filtration rate \> 70 mL/min * QTc interval \< 450 msec by EKG * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception
References
Publications (0)
Data not yet available
No reference posted for this study.