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• Conditions: recurrent or progressive medulloblastoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001512-65-CZ
• Lead Sponsor: Masaryk University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-20
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Female or male, aged between 0 and 19 years (at time of initial diagnosis)
Recurrent or progressive medulloblastoma
Measurable disease in MRI
Adequate renal, hepatic and bone marrow function
Life expectancy of > 2 months by assessment of the attending physician
Karnofsky Performance Status =50. For infants, the Lansky play scale =50% can be substituted
Written informed consent of patients and/or parents
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Active infection
VP-shunt
Pregnancy or breast feeding
Known hypersensitivity to any of the drugs in the protocol

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the Memmat trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults.;Secondary Objective: Additionally, PFS, OS, as well as feasibility and toxicity will be examined.;Primary end point(s): test of significance for clinical relevant objective treatment response