A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide with Radiotherapy in Diffuse Pontine Gliomas - Brain stem glioma temozolomide

• Conditions: Diffuse pontine glioma in children; MedDRA version: 14.0Level: PTClassification code 10006143Term: Brain stem gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-001768-60-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-06
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

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

Inclusion Criteria

a) Newly diagnosed diffuse intrinsic lesion centred in the pons on MRI imaging. No requirement for histological diagnosis. Clinical history of < 6 months. Clinical findings must include at least one of the 3 following signs of brainstem tumour i) cranial nerve deficit ii) long tract signs iii) ataxia b) Age between 2 and 21 years at initial diagnosis (i.e. up to but not including 22nd birthday) c) Patient has a Karnofsky Performance Status (KPS) or a Lansky play score of greater than or equal to 60 unless reason for decrease in status is a direct result of neurological involvement of the brainstem glioma (Appendix B). d) Patient’s laboratory values (performed within 14 days prior to study drug administration, inclusive) are as follows: i) Absolute neutrophil count (ANC) greater than or equal to 1.0 x 109/L ii) Platelet count greater than or equal to 100 x 109/L iii) Haemoglobin greater than or equal to 10 g/dL iv) Urea and serum creatinine <1.5 times upper limit of laboratory normal. v) Total and direct bilirubin <1.5 times upper limit of laboratory normal. vi) Serum AST and ALT <3 times upper limit of laboratory normal. e) Patient has life expectancy of greater than 12 weeks. f) A negative pregnancy test within 7 days prior to administration of Temozolomide for women of childbearing potential, and sexually active patients and partners agreeing to undertake adequate contraceptive measures g) Parent (and patient if appropriate) has given written informed consent. h) National and local ethical approval and regulatory approval.
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

a) Focal lesions of brainstem. b) Predominantly exophytic tumours. c) Patient has received prior chemotherapy or radiotherapy. d) Patient has frequent vomiting and/or medical condition, which could interfere with oral medication intake (e.g. partial bowel obstruction). e) Pregnant or breastfeeding women.

Study & Design

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