Metronomic and targeted anti-angiogenesis therapyfor children with recurrent/progressive medulloblastoma
- Conditions
- Recurrent/progressive medulloblastomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023691-33-CZ
- Lead Sponsor
- Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Relapsed or progressive medulloblastoma (at least one site of untreated
recurrent disease)
Histological confirmation of medulloblastoma at diagnosis or relapse
Female or male, aged from 0 to <20 years (at time of initial
diagnosis)
Participants must have normal organ and bone marrow function (ALT
<5x institutional upper limit of normal, creatinine <1.5x institutional
upper limit of normal for age, WBC >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: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Response rate (=[CR+PR+SD]/n) or lack of sign of recurrence after <br>gross total resection 6 months after start of antiangiogenic treatment.<br><br><br>;Secondary Objective: Overall survival rate<br>Progression free survival rate<br>Toxicity<br>Quality of life<br>Prognostic factors<br>Angiogenic factors<br>Pharmacokinetics<br>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 Outcome Measures
Name Time Method Secondary end point(s): Up to 8 years after start of anti-angiogenic therapy;Timepoint(s) of evaluation of this end point: 3-monthly