A Phase II study of concurrent radiation and Temozolomide followed by Temozolomide and Lomustine (CCNU) in the treatment of Children with High Grade Glioma - A phase II study with Temozolomide and Lomustine for children with high grade glioma

• Conditions: High grade glioma: anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma

• Registration Number: EUCTR2006-005077-21-NL
• Lead Sponsor: Dutch Childhood Oncology Group (DCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-20
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Children with age =/> 3 years and < 22 years, with newly diagnosed and biopsy proven high grade glioma (: anaplastic astrocytoma, glioblastoma multiforme, gliosracoma), of the brain of spine
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

Primary localisation in the brain stem; M+ disease defined as evidence of neuraxis dissemination
Karnovsky score < 50% in children > 16 years; Landsky score < 50 in children =/< 16 years
Life expectancy < 8 weeks
Prior treatment other than surgery and corticiosteroids
Abnormal organ functions
Pregnancy

Study & Design

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