Clinical trial · Interventional
Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma
Phase I Studies of TarcevaTM (Erlotinib Hydrochloride, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma
NCT00418327CI-TRIAL-00002526completedPhase 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)
The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy
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 Stem Glioma, | Brain Stem Glioma | ONTOLOGY_EXACT | 0.90 |
| Malignant Brain Tumor | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tarceva (Erlotinib Hydrochloride) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To establish the recommended dose / Maximum Tolerated Dose (MTD) the for phase II study for single agent and in combination with radiation therapy
- timeFrame
- End of recruitment
Secondary outcomes (5)
- measure
- To define Dose Limiting Toxicities (DLTs)
- timeFrame
- 3 cycles-6 cycles
- measure
- To define the safety profile
- timeFrame
- End of treatment
- measure
- To characterize the pharmacokinetic behavior of TarcevaTM in children with brain tumors as a single agent and in combination with radiation therapy
- timeFrame
- Cycles 1,2,3,4,5,6
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed malignant brain tumor * Disease must be considered refractory to first line or relapsing after conventional therapy and for which no effective conventional treatment exists.· * Newly diagnosed, histologically proven brain stem glioma, except pilocytic astrocytomas. * Age: 1 to ≤ 21 years of age at study entry * Life expectancy: at least 8 weeks * ECOG Performance status ≤ 1 or Lansky-Play Scale\>= 70%, and including children with motor paresis due to disease * Measurable or evaluable disease * No other serious concomitant illness * No organ toxicity \> grade 2 NCI-CTC AE v3.0, except alopecia and neurological symptoms due to disease Exclusion Criteria: * Patients with spontaneous intratumoral hemorrhage will not be included in the study, in exception of small post-biopsy hemorrhage due to biopsy procedure * Pregnant and breast feeding woman * Uncontrolled intercurrent illness or active infection * Chemotherapy within 4 weeks prior to study medication (within 6 weeks, if the regimen contained a nitrosourea) * Radiation therapy within 6 weeks prior to study medication * Any clinical or non-clinical evidence of pulmonary dysfunction or pre-existing lung disease * Severe cardiac pathology; history of myocardial infarction within the year prior to inclusion * Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions * Treatment with Coumarin (warfarin)
References
Publications (1)
- DERIVEDWhite-Koning M, Civade E, Geoerger B, Thomas F, Le Deley MC, Hennebelle I, Delord JP, Chatelut E, Vassal G. Population analysis of erlotinib in adults and children reveals pharmacokinetic characteristics as the main factor explaining tolerance particularities in children. Clin Cancer Res. 2011 Jul 15;17(14):4862-71. doi: 10.1158/1078-0432.CCR-10-3278. Epub 2011 Jun 8. PMID 21653689