Phase I study of TARCEVA (Erlotinib Hydrochloride, OSI-774) as a single agent in children with refractory and relapsed malignant brain tumours and in combination with irradiation in newly diagnosed brain stem glioma. - Tarceva in paediatric brain tumours

Phase 1

• Conditions: Refractory and relapsed malignant brain tumours and newly diagnosed brain stem glioma.

• Registration Number: EUCTR2004-005247-10-GB
• Lead Sponsor: The University Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

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<=21 years of age at study entry. * Life expectancy: at least 8 weeks * No concomitant anti-cancer or investigational drug (besides irradiation for group 2).*ECOG/WHO Performance status <= 2 or Lansky-Play Scale>=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

* 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the recommended/ maximum tolerated dose (MTD) for phase II studies as a single agent and in combination with irradiation. ;<br> Secondary Objective: To define Dose Limiting Toxicities (DLT's)<br> To define the safety profile<br> To characterise the pharmacokinetic behaviour of Tarceva(TM) in children with brain tumours as a single agent and in combination with irradiation.<br> To evaluate efficacy.<br> To evaluate EGFR (ERBB) expression and mutations against efficacy.<br> ;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.