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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

19. september 2013 opdateret af: Children's Cancer and Leukaemia Group

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

48

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • England
      • Birmingham, England, Det Forenede Kongerige, B4 6NH
        • Birmingham Children's Hospital
      • Bristol, England, Det Forenede Kongerige, BS2 8AE
        • Institute of Child Health at University of Bristol
      • Cambridge, England, Det Forenede Kongerige, CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Leeds, England, Det Forenede Kongerige, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, Det Forenede Kongerige, LE1 5WW
        • Leicester Royal Infirmary
      • Liverpool, England, Det Forenede Kongerige, L12 2AP
        • Royal Liverpool Children's Hospital, Alder Hey
      • London, England, Det Forenede Kongerige, WC1N 3JH
        • Great Ormond Street Hospital for Children NHS Trust
      • London, England, Det Forenede Kongerige, W1T 3AA
        • Middlesex Hospital
      • Manchester, England, Det Forenede Kongerige, M27 4HA
        • Central Manchester and Manchester Children's University Hospitals NHS Trust
      • Newcastle-Upon-Tyne, England, Det Forenede Kongerige, NE1 4LP
        • Sir James Spence Institute of Child Health
      • Nottingham, England, Det Forenede Kongerige, NG7 2UH
        • Queen's Medical Centre
      • Oxford, England, Det Forenede Kongerige, 0X3 9DU
        • Oxford Radcliffe Hospital
      • Sheffield, England, Det Forenede Kongerige, S10 2TH
        • Children's Hospital - Sheffield
      • Southampton, England, Det Forenede Kongerige, SO16 6YD
        • Southampton University Hospital NHS Trust
      • Sutton, England, Det Forenede Kongerige, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
    • Northern Ireland
      • Belfast, Northern Ireland, Det Forenede Kongerige, BT12 6BE
        • Royal Belfast Hospital for Sick Children
    • Scotland
      • Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZG
        • Royal Aberdeen Children's Hospital
      • Edinburgh, Scotland, Det Forenede Kongerige, EH9 1LF
        • Royal Hospital for Sick Children
      • Glasgow, Scotland, Det Forenede Kongerige, G3 8SJ
        • Royal Hospital for Sick Children
    • Wales
      • Cardiff, Wales, Det Forenede Kongerige, CF14 4XW
        • Childrens Hospital for Wales
  • Irland
      • Dublin, Irland, 12
        • Our Lady's Hospital for Sick Children Crumlin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy

Sekundære resultatmål

Resultatmål
Sikkerhed
Effektivitet
Dosisbegrænsende toksicitet
Pharmacokinetic behavior of erlotinib hydrocloride
Correlation of expression and mutations of epidermal growth factor receptor with treatment response

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Cancer and Leukaemia Group

Efterforskere

  • Darren Hargrave, MD, Royal Marsden NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2005

Datoer for studieregistrering

Først indsendt

3. august 2006

Først indsendt, der opfyldte QC-kriterier

3. august 2006

Først opslået (Skøn)

7. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. september 2013

Sidst verificeret

1. juni 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000481539
  • CCLG-NAG-2005-09
  • ITCC-003
  • EU-20617
  • CCLG-CPP-05-07
  • ROCHE-MO18461
  • EUDRACT-2004-005247-10

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Switzerland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

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Sponsor / samarbejdspartnere

Placeringer

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