Overview

A Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma

Status:
Active, not recruiting
Trial end date:
2028-05-01
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to investigate whether surgery and re-irradiation will help treat ependymoma that has come back after initial treatment. The combined doses of the first and second courses of radiation are higher than what is usual standard of care. The investigators will study the effects and side effects of surgery and re-irradiation. They will also evaluate and study tumor tissue and blood to learn more about the tumor and how it does or does not respond to treatments and will use magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to see if they can predict tumor response and tumor recurrence. Participants will be followed for up to 5 years following enrollment. Evaluations during radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and every 6 months during the 4th and 5th year.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Treatments:
Fluorodeoxyglucose F18
Criteria
Inclusion Criteria:

- Progressive intracranial ependymoma after prior focal irradiation

- Patients aged 1-21 years at the time of enrollment

- Adequate performance status (ECOG < 3) and research participant does not require
mechanical ventilation

- Interval from start of initial radiation therapy to enrollment > 9 months

Exclusion Criteria:

- Prior craniospinal irradiation

- Pregnant women are excluded from enrollment on this study because radiation therapy is
an agent with the potential for teratogenic or abortifacient effects

- Any patient with both metastatic ependymoma and age < 3 years at the time of
enrollment