drugset / Trial / NCT07848568

Testing Safe Doses of Anti-Cancer Medicines, 5-Flurouracil (5-FU) and Tretinoin (ATRA), Added to the Usual Cancer Treatment of Ependymoma

NCT07848568 ↗

Phase 1/2 Not yet recruiting 70 enrolled Children's Oncology Group
NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial tests the safety, side effects best dose and how well giving fluorouracil and tretinoin along with standard of care radiation therapy works for the treatment of high risk posterior fossa ependymoma that has not spread to other parts of the body (localized). Fluorouracil is a type medication called an antimetabolite. It works by stopping cells from making DNA and it may kill tumor cells. Tretinoin, also called all-trans retinoic acid (ATRA), retinoic acid, and vitamin A acid is in a class of medications called retinoids. It is made in the body from vitamin A and helps cells to grow and develop, especially in the embryo. Laboratory made form of tretinoin works by slowing or stopping the growth of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Giving fluorouracil and tretinoin along with standard of care radiation therapy may be safe, tolerable and/or effective in treating patients with localized high risk posterior fossa ependymoma.

Timeline

Start
2026-12-11
Primary completion
2037-06-30
Completion
2037-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tretinoin Unknown — Oral
Subject fluorouracil Small molecule — Intravenous