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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000570-78-IT
Enrollment
24
Registered
2006-11-29
Start date
2006-07-24
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: LASTET FIALE*IV 10F 100MG 5ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Etoposide CAS Number: 33419-42-0 Concentration unit: mg milligram(s) Concentration type: equal

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the toxicity and to determine the Maximum Tolerated Dose MTD of oral TMZ in combination with oral VP-16 administered as a single dose in children with relapsed or refractory supratentorial PNET/medulloblastoma cohort A , and relapsed or refractory malignant glial tumour grade III or IV, WHO criteria cohort B , including brain stem tumours at the diagnosis;Secondary Objective: To find the appropriate dose for subsequent phase II trials in children To assess the response rate to the combination TMZ/oral VP16;Primary end point(s): to assess the toxicity and maximum tolerated dose—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026