Metronomic and targeted anti-angiogenesis therapyfor children with recurrent/progressive medulloblastoma, ependymoma and ATRT

Phase 1

• Conditions: Recurrent/progressive medulloblastoma, ependymoma and ATRT; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023691-33-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-12
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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 <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
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified