Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
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.Inclusion Criteria
My brain tumor has grown despite previous radiation treatment.
I can care for myself and do not need a machine to help me breathe.
I am between 1 and 21 years old.
It has been over 9 months since my first radiation treatment.
Exclusion Criteria
I am under 3 years old with a type of cancer called metastatic ependymoma.
I have had radiation therapy to my brain and spine.
Treatment Details
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.
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.
Irradiation is already approved in European Union, United States, China for the following indications:
πͺπΊ Approved in European Union as Radiation therapy for:
- Medulloblastoma
- Brain tumors
- Cancer treatment
πΊπΈ Approved in United States as Radiotherapy for:
- Medulloblastoma
- Brain tumors
- Cancer treatment
π¨π³ Approved in China as Irradiation treatment for:
- Medulloblastoma
- Brain tumors
- Cancer treatment
Find a clinic near you
Research locations nearbySelect from list below to view details:
Princess Margaret Cancer CentreToronto, Canada
St. Jude Children's Research HospitalMemphis, TN
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Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor