Brain and Central Nervous System Tumors Clinical Trial
Official title:
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
Verified date | June 2007 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
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 agents |
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ireland | Our Lady's Hospital for Sick Children Crumlin | Dublin | |
United Kingdom | Royal Aberdeen Children's Hospital | Aberdeen | Scotland |
United Kingdom | Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland |
United Kingdom | Birmingham Children's Hospital | Birmingham | England |
United Kingdom | Institute of Child Health at University of Bristol | Bristol | England |
United Kingdom | Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England |
United Kingdom | Childrens Hospital for Wales | Cardiff | Wales |
United Kingdom | Royal Hospital for Sick Children | Edinburgh | Scotland |
United Kingdom | Royal Hospital for Sick Children | Glasgow | Scotland |
United Kingdom | Leeds Cancer Centre at St. James's University Hospital | Leeds | England |
United Kingdom | Leicester Royal Infirmary | Leicester | England |
United Kingdom | Royal Liverpool Children's Hospital, Alder Hey | Liverpool | England |
United Kingdom | Great Ormond Street Hospital for Children NHS Trust | London | England |
United Kingdom | Middlesex Hospital | London | England |
United Kingdom | Central Manchester and Manchester Children's University Hospitals NHS Trust | Manchester | England |
United Kingdom | Sir James Spence Institute of Child Health | Newcastle-Upon-Tyne | England |
United Kingdom | Queen's Medical Centre | Nottingham | England |
United Kingdom | Oxford Radcliffe Hospital | Oxford | England |
United Kingdom | Children's Hospital - Sheffield | Sheffield | England |
United Kingdom | Southampton University Hospital NHS Trust | Southampton | England |
United Kingdom | Royal Marsden NHS Foundation Trust - Surrey | Sutton | England |
Lead Sponsor | Collaborator |
---|---|
Children's Cancer and Leukaemia Group |
Ireland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy | Yes | ||
Secondary | Dose-limiting toxicities | Yes | ||
Secondary | Safety | Yes | ||
Secondary | Pharmacokinetic behavior of erlotinib hydrocloride | No | ||
Secondary | Efficacy | No | ||
Secondary | Correlation of expression and mutations of epidermal growth factor receptor with treatment response | No |
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