PHASE I/II STUDY OF TEMOZOLOMIDE COMBINED WITH ORAL ETOPOSIDE IN CHILDREN AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY SUPRATENTORIAL PNET/MEDULLOBLASTOMA COHORT A , AND MALIGNANT GLIAL TUMOUR COHORT B - ND

• Conditions: RELAPSED OR REFRACTORY SUPRATENTORIAL PNET/MEDULLOBLASTOMA AND MALIGNANT GLIAL TUMOUR IN CHILDREN AND YOUNG ADULTS; MedDRA version: 8.1Level: HLTClassification code 10007960Term: Central nervous system neoplasms malignant NEC

• Registration Number: EUCTR2006-000570-78-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Age at inclusion 3 years and 21 years Life expectancy 8 weeks Lansky 16 years or Karnofsky 16 years score 30 see appendix The patients should be neurologically stable or improving during the week before starting chemotherapy Haematology o Neutrophils 8805; 1.0 x109/l and o Platelets 8805; 100 x109/l Liver function o Bilirubin 8804; 1.5 x normal upper limito AST and ALT 8804; 2.5 x normal upper limit
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 or lactating females Other concomitant investigate treatment for PNET/medulloblastoma and malignant glial tumours Severe or life threatening infection Previous treatment with single TMZ or oral VP-16

Study & Design

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