Pilot institutional study evaluating 5-fluorouracil following radiation therapy in children and young adults with relapsed/refractory ependymoma. - 5-FU in relapsed Ependymoma v1.0

Royal Marsden NHS Foundation Trust0 sites0 target enrollmentJanuary 20, 2015

Overview

No summary available.

Registry

who.int

Start Date

January 20, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Patients aged 1\-24 years old at the time of informed consent.
•\- Histological confirmation of ependymoma at the time of initial diagnosis.
•\- Relapsed or progressed disease following previous standard treatment including radiotherapy. N.B.: patients suitable for re\-irradiation at the time of relapse might still be eligible for the present study.
•\- Stable neurologic examination.
•\- Measurable disease as per RECIST 1\.1\.
•\- Life expectancy of \= 12 weeks.
•\- Performance status as follows: Lansky scale \= 50% for patients \<12 years; Karnofsky \= 50% for patients \=12 years.
•\- Adequate bone marrow function at the time of eligibility assessment, defined as per full blood count on peripheral blood.
•\- Adequate liver function at the time of eligibility assessment, defined as per routine liver function tests on peripheral blood.
•\- Adequate renal function, defined as per routine parameters on peripheral blood and Glomerular Filtration Rate estimated by Schwartz formula.

•\- The patient must not have received, at the time of eligibility assessment:
•o any myelosuppressive chemotherapy within 3 weeks (exceptions: 6 weeks if prior nitrosourea, or 1 week if low dose metronomic chemotherapy);
•o any biological agent within 2 weeks;
•o focal radiotherapy within 4 weeks or craniospinal radiotherapy within 3 months;
•o any investigational therapy within 4 weeks. Investigational therapy is defined as any medicinal product that is not approved in the UK for any indication.
•\- Concomitant use of dehydropyrimidine dehydrogenase (DPD) inhibitors, such as brivudin, sorivudin and analogues within the previous 4 weeks.
•\- Patients who have an uncontrolled infection.
•\- Known active viral hepatitis, including Hepatitis A, B or C, or known diagnosis of human immunodeficiency virus (HIV) infection. Viral testing is not mandatory.
•\- Pregnant or lactating females.
•\- Low probability of treatment compliance.