5-Fluorouracil in relapsed Ependymoma

Active, not recruiting

• Conditions: Recurrent or refractory ependymoma; MedDRA version: 17.1Level: PTClassification code 10014967Term: EpendymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001470-34-GB
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-20
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

- 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.
- Adequate cardiac function at the time of eligibility assessment, defined as per previous history, physical examination, and ECG.
- Negative pregnancy test in female patients of childbearing potential.
- Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Written informed consent/assent prior to enrolment.

Are the trial subjects under 18? yes
Number of subjects for this age range: 12
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 0

Exclusion Criteria

- 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.
- Other severe, acute or chronic, medical or psychiatric condition, or laboratory abnormality, that may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: If 5-fluorouracil, given as a bolus followed by continuous infusion over 2 days, can reduce tumour burden in children and young adults with recurrent/refractory ependymoma.;Secondary Objective: If functional MRI can provide objective biomarkers that correlate with clinical outcome.;Primary end point(s): Overall response rate, complete (CR) or partial (PR), after 6 cycles of fluorouracil as per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.;Timepoint(s) of evaluation of this end point: At baseline and after 6 cycles of chemotherapy (i.e. 12 weeks).