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A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma


Phase 2
N/A
19 Years
Open (Enrolling)
Both
Medulloblastoma

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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

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