Refractory and relapsed malignant brain tumours and newly diagnosed brain stem glioma.
Conditions
Interventions
Product Name: Tarceva(TM) 150mg
Product Code: erlotinib
Pharmaceutical Form: Film-coated tablet
Product Name: Tarceva(TM) 100mg
Product
Sponsors
The University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Written informed consent of patient or parent/guardian. *Patients in group 1 must have histologically or cytologically confirmed malignant brain tumor. Disease must be considered refractory to first line or relapsing after conventional therapy or for which no effective conventional treatment exists. * Patients in group 2 must have newly diagnosed, histologically proven brain stem glioma (except pilocytic astrocytomas). *Age: 1 to=50% *Measurable or evaluable disease *Hematopoietic function; Hepatic function; Renal function: within ranges given in protocol. *No other serious concomitant illness *No organ toxicity >= grade 2 NCI-CTC AE v3.0, except alopecia and neurological symptoms due to disease *Must be able to take oral medication. Children in group 2 with some difficulties in swallowing may be allowed. *For females of childbearing potential a negative pregnancy test must be obtained before registration. *Patients wth reproductive potential must use effective contraception. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * 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 * Treatment with Coumarin (warfarin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the recommended/ maximum tolerated dose (MTD) for phase II studies as a single agent and in combination with irradiation. ; Secondary Objective: To define Dose Limiting Toxicities (DLT's) To define the safety profile To characterise the pharmacokinetic behaviour of Tarceva(TM) in children with brain tumours as a single agent and in combination with irradiation. To evaluate efficacy. To evaluate EGFR (ERBB) expression and mutations against efficacy. ;Primary end point(s): To establish the recommended/ maximum tolerated dose (MTD) for phase II studies as a single agent and in combination with irradiation. | — |
Countries
Italy, United Kingdom
Outcome results
None listed