AzTrials
AzTrials

Brain and Central Nervous System TumorsPhase 1NCT00360854

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

A Phase 1 study testing erlotinib hydrochloride, mutation analysis and polymorphism analysis in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 21 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
erlotinib hydrochloride, mutation analysis and polymorphism analysis
Type of treatment
Surgery or procedure
How many people
48 participants
Where
21 sitesin 2 countries
Study dates
May 2005to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United Kingdom20 sites

  • Royal Aberdeen Children's Hospital

    Aberdeen, Scotland, AB25 2ZG

  • Royal Belfast Hospital for Sick Children

    Belfast, Northern Ireland, BT12 6BE

  • Birmingham Children's Hospital

    Birmingham, England, B4 6NH

  • Institute of Child Health at University of Bristol

    Bristol, England, BS2 8AE

  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 2QQ

  • Childrens Hospital for Wales

    Cardiff, Wales, CF14 4XW

  • Royal Hospital for Sick Children

    Edinburgh, Scotland, EH9 1LF

  • Royal Hospital for Sick Children

    Glasgow, Scotland, G3 8SJ

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Royal Liverpool Children's Hospital, Alder Hey

    Liverpool, England, L12 2AP

  • Middlesex Hospital

    London, England, W1T 3AA

  • Great Ormond Street Hospital for Children NHS Trust

    London, England, WC1N 3JH

  • Central Manchester and Manchester Children's University Hospitals NHS Trust

    Manchester, England, M27 4HA

  • Sir James Spence Institute of Child Health

    Newcastle upon Tyne, England, NE1 4LP

  • Queen's Medical Centre

    Nottingham, England, NG7 2UH

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Children's Hospital - Sheffield

    Sheffield, England, S10 2TH

  • Southampton University Hospital NHS Trust

    Southampton, England, SO16 6YD

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Ireland1 site

  • Our Lady's Hospital for Sick Children Crumlin

    Dublin, 12

Other trials in Ireland

About this study

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

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.

Read the detailed description

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.

Being tested
erlotinib hydrochloride, mutation analysis, polymorphism analysis, laboratory biomarker analysis, pharmacological study
Keywords
untreated childhood brain stem glioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood ependymoma, recurrent childhood medulloblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood visual pathway and hypothalamic glioma, childhood central nervous system germ cell tumor, childhood choroid plexus tumor, childhood craniopharyngioma, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, childhood low-grade cerebral astrocytoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent childhood brain tumor, recurrent childhood subependymal giant cell astrocytoma, recurrent childhood pineoblastoma
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma, Familial ependymoma, Medulloblastoma, Optic Nerve Glioma, Choroid Plexus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erlotinib hydrochlorideDrug

  • mutation analysisGenetic

  • polymorphism analysisGenetic

  • laboratory biomarker analysisOther

  • pharmacological studyOther

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

  1. Dose-limiting toxicities

  2. Safety

  3. Pharmacokinetic behavior of erlotinib hydrocloride

  4. Efficacy

  5. Correlation of expression and mutations of epidermal growth factor receptor with treatment response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2006 (estimated)
  2. Study startMay 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00360854
Sponsor's protocol ID
CDR0000481539
Other IDs
CCLG-NAG-2005-09, ITCC-003, EU-20617, CCLG-CPP-05-07, ROCHE-MO18461, EUDRACT-2004-005247-10
Status last verified
Jun 2007
First submitted
3 Aug 2006
Last updated
20 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing erlotinib hydrochloride, mutation analysis and polymorphism analysis in people with Brain and Central Nervous System Tumors, run by Children's Cancer and Leukaemia Group at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00360854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.

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