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Status:

UNKNOWN

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

Lead Sponsor:

Children's Cancer and Leukaemia Group

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

1-21 years

Phase:

PHASE1

Brief 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...

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 ra...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    48 Patients enrolled

    Trial Details

    Trial ID

    NCT00360854

    Start Date

    May 1 2005

    Last Update

    September 20 2013

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    Our Lady's Hospital for Sick Children Crumlin

    Dublin, Ireland, 12

    2

    Birmingham Children's Hospital

    Birmingham, England, United Kingdom, B4 6NH

    3

    Institute of Child Health at University of Bristol

    Bristol, England, United Kingdom, BS2 8AE

    4

    Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, United Kingdom, CB2 2QQ