PHASE I / II STUDY OF SEQUENTIAL HIGH-DOSE CHEMOTHERAPY WITH STEM CELL SUPPORT IN CHILDREN YOUNGER THAN 5 YEARS OF AGE WITH HIGH-RISK MEDULLOBLASTOMA

• Conditions: High-risk medulloblastoma; MedDRA version: 16.0Level: PTClassification code 10027107Term: MedulloblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004842-14-FR
• Lead Sponsor: Institut de cancérologie Gustave Roussy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-22
• Last Update Posted: 26 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Histological diagnosis of medulloblastoma with no INI-1 loss
- High risk medulloblastoma defined by at least one of the following conditions:
Newly diagnosed classical metastatic medulloblastoma
Newly diagnosed anaplastic/large cell medulloblastoma
Newly diagnosed medulloblastoma with amplification of c-myc or N-myc
- Age at initial biopsy less or equal than 5 years
- Weight compatible with leukapheresis
- Ability to comply with requirements for submission of materials for central review
- Nutritional and general status compatible with this therapy, Lansky play score = 30%
- Estimated life expectancy =3 months
- No organ toxicity other than neurological symptoms (grade >2 according to NCI-CTC v4.0 grading system)
- No prior irradiation or chemotherapy (except VP16 – CBP)
- Written informed consent from parents or legal guardian

Inclusion criteria for the Phase I part of the study:
- Complete response after intensification phase confirmed by central review
- Adequate hepatic and renal function
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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

- Desmoplastic medulloblastoma
- Atypical Teratoid rhabdoid tumour
- Uncontrolled active or symptomatic intracranial hypertension
- Patient incapable of undergoing medical follow-up
- Relapse of medulloblastoma

Study & Design

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