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Proton Beam Therapy

Optimized Proton Therapy for Pediatric Ependymoma

Phase 1
Recruiting
Led By David R Grosshans
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lansky performance status score of 50 -100
Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
Must not have
Patients with previous radiation therapy to the brain
Ependymoma of the spine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the side effects of a new type of radiation therapy called LET optimized image modulated proton therapy in treating pediatric patients with ependymoma.

Who is the study for?
This trial is for children with a brain tumor called ependymoma, confirmed by previous tests. They should be able to perform daily activities at least half the time (Lansky score 50-100), have no tumor spread in the spine or previous brain radiation, and not be pregnant. They must also be able to undergo MRI scans and handle gadolinium contrast.
What is being tested?
The study is testing LET Optimized IMPT, a type of precise radiation therapy that targets tumors while sparing healthy tissue. It's for kids who haven't had prior radiation and aren't on chemo during the trial. The effects on quality of life will also be assessed through questionnaires.
What are the potential side effects?
Potential side effects include skin reactions near treatment areas, fatigue, headaches, hair loss at the irradiated site, nausea or vomiting. Long-term risks may involve growth development issues due to exposure of healthy tissues to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most activities but may need help.
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My cancer is only in my brain, with no spread to my spine.
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My ependymoma is confirmed to be grade II or III.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had radiation therapy to my brain.
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I have ependymoma in my spine.
Select...
I need full spine and brain radiation for my spread ependymoma.
Select...
I cannot have MRI contrast dye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Secondary study objectives
Disease outcomes following the use of a simultaneous integrated boost
Identify imaging biomarkers of structural and biological changes after proton therapy
Incidence of late and acute toxicities
+4 more

Side effects data

From 2022 Phase 2 trial • 8 Patients • NCT03690921
88%
Anemia
63%
Creatinine increased
63%
Nausea
50%
White blood cell count decreased
50%
Absolute monocyte decrease
38%
Total protein decreased
38%
Chloride level decrease
38%
Absolute eosinophil decrease
38%
Anal bleeding
38%
Anorectal pain
38%
BUN increase
25%
Constipation
25%
Hypercalcemia
25%
Fatigue
25%
PICC line pain
25%
Platelet count decreased
25%
Absolute neutrophil decrease
13%
Urinary Frequency
13%
Troponin I increased
13%
Ear fullness
13%
Hypophosphatemia
13%
Hyperkalemia
13%
Hypernatremia
13%
Hypoalbuminemia
13%
Increased LDH
13%
Low back pain
13%
Low TSH
13%
Lower extremity edema
13%
Maculopapular rash of torso
13%
Monocyte count increase
13%
Hyperglycemia
13%
Epigastric pain
13%
Hot flashes
13%
Hypoglycemia
13%
Hypomagnesemia
13%
Urinary Urgency
13%
Hyponatremia
13%
Chloride level increase
13%
High TSH
13%
Mucous discharge
13%
Nasal congestion
13%
Nosebleed
13%
Absolute lymphocyte decrease
13%
Abnormal bowel habits
13%
Absolute neutrophil increase
13%
Acute kidney disease
13%
Alkaline phosphatase increase
13%
Anal fissure
13%
Anorexia
13%
AST Increased
13%
Back pain
13%
Bilateral foot pain
13%
Binaural tinnitus
13%
Bladder incontinence
13%
Bowel incontinence
13%
Bowel urgency
13%
Carbon Dioxide Decreased
13%
Chest pain (non-cardiac)
13%
Dermatitis
13%
Difficulty with sleep
13%
Dizziness
13%
Dyspaurenia
13%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
IMPT for Anal Cancer (Single Arm Trial)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (LET optimized IMPT)Experimental Treatment3 Interventions
Patients receive LET optimized IMPT for up to 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
2018
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,533 Total Patients Enrolled
81 Trials studying Ependymoma
8,696 Patients Enrolled for Ependymoma
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,443 Total Patients Enrolled
4 Trials studying Ependymoma
36 Patients Enrolled for Ependymoma
David R GrosshansPrincipal InvestigatorM.D. Anderson Cancer Center
~17 spots leftby Dec 2027
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