Protocol
SJREFU: A Phase I Study of 5-Fluorouracil In Children And Young Adults With Recurrent Ependymoma
Diseases
Brain Tumor : Recurrent ependymoma
Description
Ependymoma is a rare type of primary brain or spinal cord tumor. Primary brain and spinal cord tumors start in the central nervous system (CNS). Occasionally, ependymoma tumor cells can spread in the cerebrospinal fluid (CSF) . Although it is very rare for ependymoma to occur in other parts of the body, the tumor cells in the CSF can cause tumors to develop in other areas of the CNS. Typically, tumor nodules form where the tumor cells settle such as at the base of the brain or bottom of the spinal cord. This type of tumor can be difficult to treat when it recurs. At this time, there is no chemotherapy treatment that has been proven to be very effective in the majority of children with recurrent disease.
This is a phase I study of a drug called 5-Fluorouracil (5-FU). This drug has been approved by the FDA and commercially available for many years. It is a drug commonly used to treat a variety of cancers (both in children and adults); however, 5-FU is not approved by the FDA to treat brain tumors in children. This drug has been used in the past for adults with brain tumors, but it was given in a different way. This is why the treatment is considered experimental (research). This study is being done to find out the best dose to give children and young adults with relapsed or recurrent ependymoma so that future studies with this drug can be done.
Objectives
- To find the highest safe dose of 5-FU that can be given without causing severe side effects
- To learn more about how children and young adults absorb, distribute, break down, and remove 5-FU from the body (called pharmacokinetics or PK studies)
- To learn more about the side effects of 5-FU in children and young adults
- To collect preliminary (early) information to find out if this treatment will have any effect on ependymoma in children and young adults
- To learn more about the biology and genetics of ependymoma, and if genetic changes in some participants may cause them to have more side effects from 5-FU
Eligibility
- Participant must be less than 22 years (eligible until 22nd birthday) of age at the time of enrollment.
- Participants with uncontrolled infection, receiving any other anticancer or experimental treatment are not eligible for the study
- Participants must not breastfeed while on this study
- Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to study entry.
- Patients must have a negative test for a certain enzyme change in the body that could cause them to get sick from the drug.
Contact
Karen Wright, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Phone: 901-595-2544 or 901-595-4599
FAX: 901-595-5353
Or
Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544
For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.