Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01356290 : Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma
PhasePhase 2
AgesMin: N/A Max: 19 Years
Eligibility
Inclusion Criteria:

- 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 original 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

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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01356290      |      Link to official Clinicaltrials.gov listing
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