Ependymoma Clinical Trial
Official title:
Phase I Study of 5-Fluorouracil in Children and Young Adults With Recurrent Ependymoma
This is a phase I study to investigate the safety and pharmacokinetics of weekly 5-fluorouracil (5-FU) administered as a bolus dose in children and young adults with recurrent or refractory ependymoma. The results from this study will inform a subsequent phase II St. Jude investigator-initiated trial.
The initial 5-FU dosage will be 500 mg/m^2 administered on day 1 of course 1. We plan to
treat a maximum of 3 cohorts of research participants (dosage levels - 0, 1, and 2) with
escalating doses of 5-FU. A cycle is defined as 42 days. The first 6 weeks of therapy will
constitute the dose-limiting toxicity (DLT) evaluation period.
Primary objective
- To investigate the safety and pharmacokinetics (plasma and cerebrospinal fluid) of
weekly bolus dose 5-FU in children and young adults with recurrent/refractory
ependymoma
- To study the safety of 500 mg/m^2 weekly bolus dose 5-FU in less-heavily pre-treated
children and young adults with recurrent/refractory ependymoma.
Secondary objectives
- To document and describe toxicities associated with 5-FU administered on a weekly bolus
schedule
- To document preliminary antitumor activity in participants with recurrent or refractory
ependymoma treated with 5-FU
- To assess the feasibility of measuring expression level of Thymidylate Synthetase
(TYMS) in formalin fixed paraffin embedded (FFPE) tumor samples using the Quantigene
assay
- To evaluate the association between specific genetic polymorphisms (e.g., DPYD) and the
pharmacokinetics of 5-FU
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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