Surgery + Re-Irradiation for Recurrent Ependymoma

Recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: St. Jude Children's Research Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

68 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for recurrent ependymoma?

Research shows that re-irradiation (repeated radiation therapy) can be effective for treating recurrent ependymoma, as it helps manage the disease when it comes back. Surgery to remove as much of the tumor as possible, followed by radiation therapy, has been shown to improve survival rates in patients with ependymoma. ^{1 2 3 4 5}

Is surgery and re-irradiation safe for treating recurrent ependymoma?

Re-irradiation for recurrent ependymoma can provide long-term disease control with low rates of severe side effects when done carefully to minimize exposure to sensitive areas. ^{4 6 7 8 9}

How is the treatment of surgery and re-irradiation for recurrent ependymoma different from other treatments?

This treatment is unique because there is no standard treatment for recurrent ependymomas, and re-irradiation combined with surgery is being explored as a potential option. Unlike other treatments, this approach focuses on re-treating the tumor with radiation after surgery, which is still being studied for its effectiveness. ^{2 5 8 10 11}

Research Team

Thomas Merchant

Principal Investigator

St. Jude Children's Research Hospital

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.

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

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

Exclusion Criteria

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

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

I have had radiation therapy to my brain and spine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo surgery as part of the treatment for recurrent ependymoma

1 week

Radiation Therapy

Participants receive fractionated re-irradiation therapy, with evaluations done weekly

7 weeks

Weekly visits during therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 4 months for 3 years, then every 6 months for 2 years

Treatment Details

Interventions

• Irradiation
• Surgery

Trial Overview 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.

Participant Groups

Group I: Stratum 4: Local Failure Experimental Treatment 6 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 Failure Experimental Treatment 6 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 Failure Experimental Treatment 6 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 Failure Experimental Treatment 6 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:

Approved in European Union as Radiation therapy for:

• Medulloblastoma
• Brain tumors
• Cancer treatment

Approved in United States as Radiotherapy for:

• Medulloblastoma
• Brain tumors
• Cancer treatment

Approved in China as Irradiation treatment for:

• Medulloblastoma
• Brain tumors
• Cancer treatment

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Findings from Research

Complete surgical resection of ependymomas significantly improves patient survival, making it crucial to evaluate the extent of disease through cerebrospinal fluid cytology and MRI before deciding on treatment.

For patients with residual disease who cannot undergo further surgery, limited-field radiotherapy is typically used, but the effectiveness of craniospinal irradiation remains debated due to the tendency for local recurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ependymomas. Chowdhary, S., Green, MR., Chamberlain, M.[2022]

Radiotherapy (RT) for spinal ependymoma, particularly in patients with adverse features like incomplete resection or disseminated disease, resulted in a 5-year overall survival rate of 83.7% and a progression-free survival rate of 70.8% based on a study of 25 patients.

Patients with grade I ependymoma had significantly better survival outcomes compared to those with grade II/III, indicating that tumor grade is an important factor in predicting the effectiveness of RT, while the treatment was generally safe with minimal late toxicities observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of radiotherapy for spinal cord ependymoma with adverse prognostic features: a single-center study. Byun, HK., Yi, S., Yoon, HI., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Re-irradiation of locally recurrent pediatric intracranial ependymoma: Experience of the French society of children's cancer. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Extent of re-excision, sequence/timing of salvage re-irradiation, and disease-free interval impact upon clinical outcomes in recurrent/progressive ependymoma. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Outcome of postoperative radiation therapy for pediatric intracranial ependymoma: a single-institution review. [2020]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Ependymoma: a Retrospective Analysis of 25 Cases. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Ependymomas. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes of radiotherapy for spinal cord ependymoma with adverse prognostic features: a single-center study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Re-irradiation for Paediatric Tumours. [2020]

8. Austria pubmed.ncbi.nlm.nih.gov

Recurrent spinal ependymoma showing partial remission under Imatimib. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Conformal radiotherapy after surgery for paediatric ependymoma: a prospective study. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Re-irradiation of recurrent pediatric ependymoma: modalities and outcomes: a twenty-year survey. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Postoperative irradiation of brain ependymomas. Analysis of 33 cases. [2019]