Clinical Trial Details
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[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.]

NCT02265770 : An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma
PhasePhase 2/Phase 3
AgesMin: N/A Max: 22 Years
Eligibility
After Initial surgery, patients will be enrolled in one of 3 different interventional
strata where they will be offered a set of therapeutic interventions based on the outcome
of the intervention (no measurable residue vs residual inoperable disease), their age
and/or their eligibility /suitability to receive radiotherapy.

Patients with centrally and histologically confirmed intracranial ependymoma meeting the
following criteria will be enrolled into one of interventional stratum:

- Age < 22 years old at diagnosis

- Newly diagnosed with an ependymoma WHO grade II and III, including ependymoma
variants: papillary, clear-cell and tanycytic, RELA fusion positive or anaplastic
ependymoma

- Post-menarchal female not pregnant or nursing (breast feeding) and with a negative
beta-HCG pregnancy test prior to commencing the trial

- Males and females of reproductive age and childbearing potential with effective
contraception for the duration of their treatment and 6 months after the completion of
their treatment

- No contraindication to the use if one of the study drugs proposed by the protocol

- Patients and/or their parents or legal guardians willing and able to comply with
scheduled visits, treatment plan, laboratory tests and other study procedure

Common inclusion criteria for Strata 1 and 2:

- Age > 12 months and < 22 years at time of study entry

- Histologically confirmed WHO Grade II-III ependymoma by central pathological review

- No metastasis on spinal MRI and on CSF cytology assessments

- No previous radiotherapy

- No previous chemotherapy (except steroids)

- No co-existent unrelated disease at the time of study entry that would render the
patient unable to receive chemotherapy

- No medical contraindication to radiotherapy and chemotherapy

- No signs of infection

- Adequate bone marrow, liver and renal functions

Specific inclusion criteria for Stratum 1:

• No residual measurable ependymoma based on the central neuroradiological review (R0-1-2)

Specific inclusion criteria for Stratum 2:

• Residual non reoperable measurable ependymoma based on the central neuroradiological
review (R3-4)

Inclusion criteria for Stratum 3:

- Children younger than 12 months at time of entry to study or any children ineligible
to receive radiotherapy due to age at diagnosis, tumour location or clinician / parent
decision and according to national criteria

- Histologically confirmed WHO Grade II-III ependymoma by central pathological review

- Adequate bone marrow, liver and renal functions

- No previous chemotherapy and radiotherapy

- No contraindication to chemotherapy

- No co-existent unrelated disease at the time of study entry that would render the
patient unable to receive chemotherapy

- No signs of infection. Patients that do not fulfill the inclusion criteria of one of
the interventional strata will be enrolled and followed up into an observational study
and descriptive analysis will be performed.

EXCLUSION CRITERIA for all interventional strata:

- Tumour entity other than primary intracranial ependymoma

- Primary diagnosis predating the opening of SIOP Ependymoma II

- Patients with WHO grade I ependymoma including ependymoma variants: myxopapillary
ependymomas and subependymomas,patients with spinal cord location of the primary
tumour

- Participation within a different trial for treatment of ependymoma

- Contraindication to one of the IMP used according to the SmPCs

- Concurrent treatment with any anti-tumour agents

- Inability to tolerate chemotherapy

- Unable to tolerate intravenous hydration

- Pre-existing mucositis, peptic ulcer, inflammatory bowel disease ascites, or pleural
effusion.

Strata 1 and 2:

- Ineligible to receive radiotherapy

- Patient for whom imaging remains RX despite all effort to clarify the MRI conclusion

Stratum 3:

- Pre-existing severe hepatic and/or renal damage

- Family history of severe epilepsy

- Presence of previously undiagnosed mitochondrial disorder detected by screening as
part of trial

- Elevated blood ammonium and lactate level = 1.5 x upper limit of the normal
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02265770      |      Link to official Clinicaltrials.gov listing
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