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A Phase II study of metronomic and targeted anti-angiogenesis therapy for children with recurrent/progressive medulloblastoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-001512-65-CZ
Enrollment
40
Registered
2012-04-20
Start date
2012-06-19
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

recurrent or progressive medulloblastoma

Interventions

Trade Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion Product Name: thalidomide Pharmaceutical Form: Capsule Product Name: Celecoxib Pharmaceutical Form: Capsule Product N

Sponsors

Masaryk University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Czech Republic

Contacts

Public ContactDepartment of Pharmacology

Masaryk University

demlova@med.muni.cz00420549493070

Outcome results

None listed

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