Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)