NCT00418327

Brief Summary

The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

First QC Date

January 3, 2007

Last Update Submit

August 6, 2009

Conditions

Malignant Brain TumorBrain Stem Glioma,

Keywords

Tarcevarefractory and relapsed malignant brain tumorsnewly diagnosed brain stem glioma

Outcome Measures

Primary Outcomes (1)

  • To establish the recommended dose / Maximum Tolerated Dose (MTD) the for phase II study for single agent and in combination with radiation therapy

    End of recruitment

Secondary Outcomes (5)

  • To define Dose Limiting Toxicities (DLTs)

    3 cycles-6 cycles

  • To define the safety profile

    End of treatment

  • To characterize the pharmacokinetic behavior of TarcevaTM in children with brain tumors as a single agent and in combination with radiation therapy

    Cycles 1,2,3,4,5,6

  • To evaluate efficacy

    Cycles 2,4,6, end of treatment

  • To evaluate expression and mutations of EGFR with efficacy

    End of treatment

Interventions

Tarceva (Erlotinib Hydrochloride)DRUG

tablets of 25 mg, 100 mg and 150 mg 75 to 150 mg/m² Once daily

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically or cytologically confirmed malignant brain tumor
  • Disease must be considered refractory to first line or relapsing after conventional therapy and for which no effective conventional treatment exists.·
  • Newly diagnosed, histologically proven brain stem glioma, except pilocytic astrocytomas.
  • Age: 1 to ≤ 21 years of age at study entry
  • Life expectancy: at least 8 weeks
  • ECOG Performance status ≤ 1 or Lansky-Play Scale\>= 70%, and including children with motor paresis due to disease
  • Measurable or evaluable disease
  • No other serious concomitant illness
  • No organ toxicity \> grade 2 NCI-CTC AE v3.0, except alopecia and neurological symptoms due to disease

You may not qualify if:

  • Patients with spontaneous intratumoral hemorrhage will not be included in the study, in exception of small post-biopsy hemorrhage due to biopsy procedure
  • Pregnant and breast feeding woman
  • Uncontrolled intercurrent illness or active infection
  • Chemotherapy within 4 weeks prior to study medication (within 6 weeks, if the regimen contained a nitrosourea)
  • Radiation therapy within 6 weeks prior to study medication
  • Any clinical or non-clinical evidence of pulmonary dysfunction or pre-existing lung disease
  • Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
  • Treatment with Coumarin (warfarin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

  • White-Koning M, Civade E, Geoerger B, Thomas F, Le Deley MC, Hennebelle I, Delord JP, Chatelut E, Vassal G. Population analysis of erlotinib in adults and children reveals pharmacokinetic characteristics as the main factor explaining tolerance particularities in children. Clin Cancer Res. 2011 Jul 15;17(14):4862-71. doi: 10.1158/1078-0432.CCR-10-3278. Epub 2011 Jun 8.

    PMID: 21653689DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Vassal Gilles, Pr.

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

June 1, 2005

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

FR(1)