← Back to Search

Radiation Therapy

Surgery + Re-Irradiation for Recurrent Ependymoma

Phase 2

Waitlist Available

Led By Thomas E. Merchant, DO, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Progressive intracranial ependymoma after prior focal irradiation

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

Must not have

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

Prior craniospinal irradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and at 12, 24 and 36 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people with ependymoma that has come back after initial treatment. Surgery and re-irradiation with higher than usual doses of radiation will be used to try to treat the tumor. Tumor tissue and blood will be studied to learn more about the tumor and how it responds to treatments.

Who is the study for?

This trial is for individuals aged 1-21 with recurrent ependymoma, a type of brain tumor, after initial radiation treatment. They must be at least 9 months post-initial therapy and able to perform daily activities without mechanical ventilation. Pregnant women, patients who had prior full-spine irradiation or are under 3 years old with metastatic ependymoma cannot participate.

What is being tested?

The study tests if surgery combined with higher-than-usual doses of re-irradiation can treat recurring ependymoma. It includes analyzing tumor tissue and blood samples, using MRI and PET scans to monitor the tumor's response to treatments over a period of up to five years.

What are the potential side effects?

Potential side effects may include typical risks associated with surgery and radiation such as fatigue, skin irritation at the irradiated site, hair loss in the treated area, nausea, headaches, and more serious complications like damage to surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My brain tumor has grown despite previous radiation treatment.

Select...

I can care for myself and do not need a machine to help me breathe.

Select...

I am between 1 and 21 years old.

Select...

It has been over 9 months since my first radiation treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 3 years old with a type of cancer called metastatic ependymoma.

Select...

I have had radiation therapy to my brain and spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and at 12, 24 and 36 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, and at 12, 24 and 36 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and at 12, 24 and 36 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

3-year Overall Survival Rate

3-year Progression-free Survival Rate

Secondary study objectives

Change Over Time in Imaging Metrics

Incidence Rate of Audiological Deficits

Incidence Rate of Endocrine Deficits

+20 more

Other study objectives

Avidity of Ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET Prior to Radiation Therapy

Genetic Variations in Germline

Longitudinal Change of Avidity of Ependymoma to 18F-fluorodeoxyglucose and 11C-methionine PET Prior to Radiation Therapy

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Stratum 4: Local FailureExperimental Treatment6 Interventions

Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is \>36 months at time of enrollment to \<21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation. Participants may receive one or both: Photon therapy or proton therapy. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine to aid in tumor visualization.

Group II: Stratum 3: Local and Metastatic FailureExperimental Treatment6 Interventions

Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Participants may receive one or both: Photon therapy or proton therapy. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine to aid in tumor visualization.

Group III: Stratum 2: Metastatic FailureExperimental Treatment6 Interventions

Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume. Participants may receive one or both: Photon therapy or proton therapy. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine to aid in tumor visualization.

Group IV: Stratum 1: Local FailureExperimental Treatment6 Interventions

Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy. Participants may receive one or both: Photon therapy or proton therapy. Participants receive \^1\^8F-fluorodeoxyglucose and \^1\^1C-methionine to aid in tumor visualization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irradiation

2015

N/A

~490

Proton therapy

2011

N/A

~30