Recurrent/progressive medulloblastoma, ependymoma and ATRT
Conditions
Interventions
Trade Name: Avastin
Product Name: Bevacizumab
Pharmaceutical Form:
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Trade Name: Thalidomide Celgene
Product Name: Thalidomide
Pharmaceutical F
Sponsors
Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Relapsed or progressive medulloblastoma, ependymoma or ATRT (at least one site of untreated recurrent disease) Histological confirmation of medulloblastoma at diagnosis or relapse Female or male, aged from 0 to 1000/mm3, platelets > 20,000/mm3. Patients with values less than WBC 2000/mm3 or platelets 50,000/mm3 will require initiation of treatment with etoposide and cyclophosphamide at a lower starting dose as defined within the protocol. Karnofsky performance status =50. For infants and children less than 12 years of age, the Lansky play scale =50% will be used Written informed consent of patients and / or parents Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 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 dependency Pregnancy or breast feeding Conventional chemotherapy, antiangiogenic treatment or complete irradiation of all disease for current relapse (surgery may be performed before antiangiogenic treatment; patients with sites of disease not irradiated are still eligible for the protocol) Known hypersensitivity to any of the drugs in the protocol Active peptic ulcer Any significant cardiovascular disease not controled by standard therapy e.g. systemic hypertension Anticipation of the need for major elective surgery during the course of the study treatment Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications Non-healing surgical wound A bone fracture that has not satisfactorily healed Any significant cardiovascular disease e.g. systemic hypertension Anticipation of the need for major elective surgery during the course of the study treatment Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications Non-healing surgical wound A bone fracture that has not satisfactorily healed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate (=[CR+PR+SD]/n) or lack of sign of recurrence after gross total resection 6 months after start of antiangiogenic treatment.;Secondary Objective: Overall survival rate Progression free survival rate Toxicity Quality of life Prognostic factors Angiogenic factors Pharmacokinetics Tumor/angiogenic markers;Primary end point(s): Test of significance for clinical relevant objective treatment response;Timepoint(s) of evaluation of this end point: 6 months after start of anti-angiogenic therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Up to 8 years after start of anti-angiogenic therapy;Timepoint(s) of evaluation of this end point: 3-monthly | — |
Countries
Austria, Belgium, Czechia, Czech Republic, Denmark, France, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactUniversitätskinderklinik
Medizinische Universität Wien
Outcome results
None listed