Clinical Trial Details
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NCT01498783 : Phase I Study of 5-Fluorouracil in Children and Young Adults With Recurrent Ependymoma
PhasePhase 1
AgesMin: 1 Month Max: 21 Years

- Participant must have recurrent or refractory intracranial or spinal ependymoma
(including myxopapillary, clear cell, papillary, tanycytic and anaplastic ependymoma
or subependymoma). The diagnosis must be confirmed by the pathologist on tissue
obtained at either initial diagnosis or at time of recurrence prior to registration.

- Participants may have had two prior systemic anti-cancer chemotherapy regimens,
including any chemotherapy, biologic modifiers or small molecules. These may have
been given either before or after irradiation.

- Participant must be < 22 years (eligible until 22nd birthday) of age at the time of

- Negative testing for DPYD*2 any time prior to enrollment (does not need to be within
7 days)

- Neurologic deficits: Participants with neurological deficits should have a stable or
improving neurologic exam for a minimum of 1 week prior to study registration.

- Performance level: Karnofsky Performance Scale (participants > 16 years of age) or
Lansky Performance Score (participants ? 16 years of age) must be > 30 within two
weeks prior to registration.

- Chemotherapy: Participants must have received their last dose of known
myelosuppressive anticancer chemotherapy at least four weeks prior to study
registration or at least six weeks if nitrosurea. At least two weeks must have
lapsed if participants received lower dose oral etoposide (50 mg/m^2) without
experiencing evidence of myelosuppression (i.e., neutropenia or requiring transfusion
with blood products).

- Biologic agent: Participant must have recovered from any toxicity potentially related
to the agent and received their last dose of the biologic agent ? 7 days prior to
study registration. For biologic agents that have a prolonged half-life, the
appropriate interval since last treatment should be discussed with the PI prior to

- Monoclonal antibody treatment: At least three half-lives must have elapsed prior to
registration. Such participants should be discussed with the PI prior to registration

- XRT: No more than two prior radiation regimens. For participants who have had prior
irradiation for treatment of their ependymoma. XRT must be:

- ? 6 months prior to registration if treated with craniospinal irradiation (? 18

- ? 4 weeks prior to registration if treated with focal irradiation to the
primary tumor

- ? 2 weeks prior to registration if treated with focal irradiation to symptomatic
metastatic sites

- Bone marrow or stem cell transplant: Participant must be ? 3 months since high dose
chemotherapy and peripheral blood stem cell rescue prior to registration

- Anti-convulsants: Participants with seizure disorder may be enrolled if well
controlled on anti-epileptic drugs.

- Corticosteroids: Participants who are taking corticosteroids must be on a stable or
decreasing dose for at least 1 week prior to registration.

- Growth factors: Participants must be off all colony forming growth factors(s) for at
least 1 week prior to registration (e.g. filgrastim, sargramostim, erythropoietin)
and at least 2 weeks for long-acting formulations (e.g. Neupogen®).

- Adequate organ function at the time of study enrollment as defined as follows:
Laboratory values must be assessed within 7 days prior to registration and must be
repeated if initial labs were done greater than 7 calendar days prior to the start of

- Bone marrow: Absolute neutrophil count (ANC) ? 500/?L, platelet count ?
50,000/?L (transfusion independent), hemoglobin concentration ? 8g/dL (may be

- Renal: Normal serum creatinine concentration based on age or GFR >

- Hepatic: Total bilirubin concentration < 1.5x the institutional upper limit of
normal for age; SGPT and SGOT < 2.5 x the institutional upper limit of normal


- Participants may not have been previously treated with 5-FU

- Participants receiving any other anticancer or experimental treatment

- Participants with uncontrolled infection

- Participants with any concomitant significant medical illness that in the
investigator's opinion cannot be adequately controlled with appropriate therapy, or
that would compromise the participant's ability to tolerate therapy, impair the
evaluation of side effects related to this treatment, or alter drug metabolism

- Females of childbearing potential must have a negative serum or urine pregnancy test
within 7 days prior to study entry.

- Participants of child bearing potential must agree to use an effective contraceptive

- Participants must not breastfeed while on this study
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