Status:
COMPLETED
Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Malignant Brain Tumor
Brain Stem Glioma,
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
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
Detailed Description
Prognosis in relapsing malignant brain tumors is poor. Those in brain stem gliomas is dismal; median survival of these children does not exceed 9 months. Radiation therapy may result in early and tran...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Severe cardiac pathology; history of myocardial infarction within the year prior to inclusion
- 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)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00418327
Start Date
June 1 2005
Last Update
August 7 2009
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94805