Clinical trial · Interventional
Erlotinib Alone or in Combination With Radiation Therapy in Treating Young Patients With Refractory or Relapsed Malignant Brain Tumors or Newly Diagnosed Brain Stem Glioma
Phase I Studies of TARCEVA™ (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
- 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: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given alone or together with radiation therapy in treating young patients with refractory or relapsed malignant brain tumors or newly diagnosed 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 | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy
Secondary outcomes (5)
- measure
- Dose-limiting toxicities
- measure
- Safety
- measure
- Pharmacokinetic behavior of erlotinib hydrocloride
- measure
- Efficacy
- measure
- Correlation of expression and mutations of epidermal growth factor receptor with treatment response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Histologically or cytologically confirmed malignant brain tumor
* Refractory to first-line therapy or relapsed after conventional therapy
* No effective conventional therapy exists
* Histologically confirmed brain stem glioma
* Newly diagnosed disease
* No pilocytic glioma
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
* WHO performance status 0-2 OR Lansky play scale 50-100%
* Patients with motor paresis due to disease are eligible
* Neurological deficits must be stable for ≥ 1 week
* Life expectancy ≥ 8 weeks
* Absolute neutrophil count \> 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8 g/dL
* AST/ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Creatinine \< 1.5 times ULN OR creatinine clearance ≥ 70 mL/min
* No other serious, uncontrolled illness
* No active infection
* No organ toxicity ≥ grade 2 except alopecia and neurological symptoms due to disease
* Must be able to take oral medication
* Patients with newly diagnosed brain stem glioma with difficulty swallowing may be eligible
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No evidence of pulmonary dysfunction or pre-existing lung disease
* No myocardial infarction within the past year
* No severe cardiac pathology
* No significant ophthalmologic abnormality including, but not limited to, any of the following:
* Severe dry eye syndrome
* Keratoconjunctivitis sicca
* Sjögren's syndrome
* Severe exposure keratitis
* Any other disorder likely to increase the risk of corneal epithelial lesions
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* More than 6 weeks since prior radiotherapy
* No concurrent warfarin
* No other concurrent anticancer or investigational agentsReferences
Publications (0)
Data not yet available