- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00360854
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
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
OBJECTIVES:
Primary
- Establish the maximum tolerated dose of single-agent erlotinib hydrochloride in pediatric patients with refractory or relapsed malignant brain tumors and in combination with radiotherapy in pediatric patients with newly diagnosed brain stem glioma.
Secondary
- Determine dose-limiting toxicities of these regimens.
- Define the safety profile of these regimens.
- Characterize the pharmacokinetic behavior of erlotinib hydrochloride in these patients.
- Evaluate the efficacy of these regimens.
- Correlate expression and mutations of epidermal growth factor receptor with treatment response.
OUTLINE: This is a multicenter, nonrandomized, open-label, dose-escalation study of erlotinib hydrochloride. Patients are assigned to 1 of 2 treatment groups according to disease.
- Group 1 (refractory or relapsed malignant brain tumors): Patients receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
- Group 2 (newly diagnosed brain stem glioma): Patients receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. Beginning on day 1, patients also undergo radiotherapy 5 days a week for 6 weeks .
Cohorts of 1-2 patients receive escalating doses of erlotinib hydrochloride until the MTD is determined. The MTD is defined as the dose resulting in 25% of patients experiencing DLT at 6 weeks.
Blood is collected for pharmacokinetic assessments and pharmacogenetic genotyping for analysis of enzyme polymorphisms. Tumor tissue may be assessed for epidermal growth factor receptor mutations.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 1
Kontakter och platser
Studieorter
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Dublin, Irland, 12
- Our Lady's Hospital for Sick Children Crumlin
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England
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Birmingham, England, Storbritannien, B4 6NH
- Birmingham Children's Hospital
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Bristol, England, Storbritannien, BS2 8AE
- Institute of Child Health at University of Bristol
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Cambridge, England, Storbritannien, CB2 2QQ
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
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Leeds, England, Storbritannien, LS9 7TF
- Leeds Cancer Centre at St. James's University Hospital
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Leicester, England, Storbritannien, LE1 5WW
- Leicester Royal Infirmary
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Liverpool, England, Storbritannien, L12 2AP
- Royal Liverpool Children's Hospital, Alder Hey
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London, England, Storbritannien, WC1N 3JH
- Great Ormond Street Hospital for Children NHS Trust
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London, England, Storbritannien, W1T 3AA
- Middlesex Hospital
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Manchester, England, Storbritannien, M27 4HA
- Central Manchester and Manchester Children's University Hospitals NHS Trust
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Newcastle-Upon-Tyne, England, Storbritannien, NE1 4LP
- Sir James Spence Institute of Child Health
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Nottingham, England, Storbritannien, NG7 2UH
- Queen's Medical Centre
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Oxford, England, Storbritannien, 0X3 9DU
- Oxford Radcliffe Hospital
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Sheffield, England, Storbritannien, S10 2TH
- Children's Hospital - Sheffield
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Southampton, England, Storbritannien, SO16 6YD
- Southampton University Hospital NHS Trust
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Sutton, England, Storbritannien, SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
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Northern Ireland
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Belfast, Northern Ireland, Storbritannien, BT12 6BE
- Royal Belfast Hospital for Sick Children
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Scotland
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Aberdeen, Scotland, Storbritannien, AB25 2ZG
- Royal Aberdeen Children's Hospital
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Edinburgh, Scotland, Storbritannien, EH9 1LF
- Royal Hospital for Sick Children
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Glasgow, Scotland, Storbritannien, G3 8SJ
- Royal Hospital for Sick Children
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Wales
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Cardiff, Wales, Storbritannien, CF14 4XW
- Childrens Hospital for Wales
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy
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Sekundära resultatmått
Resultatmått |
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Säkerhet
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Effektivitet
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Dosbegränsande toxicitet
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Pharmacokinetic behavior of erlotinib hydrocloride
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Correlation of expression and mutations of epidermal growth factor receptor with treatment response
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Samarbetspartners och utredare
Utredare
- Darren Hargrave, MD, Royal Marsden NHS Foundation Trust
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- obehandlat hjärnstamgliom från barndomen
- barndomens infratentoriella ependymom
- supratentoriellt ependymom i barndomen
- återkommande supratentoriell primitiv neuroektodermal tumör i barndomen
- återkommande cerebellära astrocytom i barndomen
- återkommande cerebralt astrocytom i barndomen
- återkommande barndomsependymom
- återkommande hjärntumör i barndomen
- återkommande medulloblastom i barndomen
- återkommande synväg i barndomen och hypotalamusgliom
- barndoms kraniofaryngiom
- barndomens centrala nervsystemets könscellstumör
- barndoms choroid plexus tumör
- meningiom i barndomsgrad I
- meningiom i barndomsgrad II
- meningiom i barndomsgrad III
- barndom låggradigt cerebralt astrocytom
- återkommande pineoblastom i barndomen
- återkommande subependymala jättecellastrocytom hos barn
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Neoplasmer, neuroepitelial
- Neuroektodermala tumörer
- Neoplasmer, könsceller och embryonala
- Neoplasmer, nervvävnad
- Gliom
- Neoplasmer i hjärnan
- Neoplasmer i nervsystemet
- Neoplasmer i centrala nervsystemet
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Proteinkinashämmare
- Erlotinib hydroklorid
Andra studie-ID-nummer
- CDR0000481539
- CCLG-NAG-2005-09
- ITCC-003
- EU-20617
- CCLG-CPP-05-07
- ROCHE-MO18461
- EUDRACT-2004-005247-10
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