Trial Information
A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma
Inclusion Criteria:
- Female or male, aged between 0 and 19 years (at time of initial diagnosis)
- Recurrent or progressive medulloblastoma
- Measurable disease in magnetic resonance imaging (MRI)
- Adequate renal, hepatic and bone marrow function
- Life expectancy of > 2 months by assessment of the attending physician
- Karnofsky Performance Status (KPS) ≥50. For infants Lansky play scale ≥50%
- Written informed consent of patients and/or parents
Exclusion Criteria:
- Active infection
- Ventricular-peritoneal (VP)-shunt
- Pregnancy or breast feeding
- Known hypersensitivity to any of the drugs in the protocol
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Outcome Description:
Response rate (Complete remission, partial response, stable disease =[CR+PR+SD]/n) 6 months after start of antiangiogenic treatment
Outcome Time Frame:
7 years
Safety Issue:
No
Principal Investigator
Andreas Peyrl, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of Vienna
Authority:
Austria: Agency for Health and Food Safety
Study ID:
MUV-MEMMAT-01
NCT ID:
NCT01356290
Start Date:
April 2011
Completion Date:
April 2018
Related Keywords:
- Medulloblastoma
- Medulloblastoma
- Relapse
- Children
- antiangiogenic
- metronomic
- intrathecal
- Medulloblastoma