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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post-treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

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%

Anorectal pain

38%

BUN increase

38%

Chloride level decrease

38%

Absolute eosinophil decrease

38%

Anal bleeding

25%

Constipation

25%

Platelet count decreased

25%

Fatigue

25%

Absolute neutrophil decrease

25%

Hypercalcemia

25%

PICC line pain

13%

Epigastric pain

13%

Low back pain

13%

Troponin I increased

13%

Absolute lymphocyte decrease

13%

Chest pain (non-cardiac)

13%

Dyspaurenia

13%

Hot flashes

13%

Dermatitis

13%

Ear fullness

13%

Binaural tinnitus

13%

Hyperkalemia

13%

Hypoglycemia

13%

Maculopapular rash of torso

13%

Nasal congestion

13%

Urinary Frequency

13%

Absolute neutrophil increase

13%

Bowel urgency

13%

Increased LDH

13%

AST Increased

13%

Alkaline phosphatase increase

13%

Back pain

13%

Hypoalbuminemia

13%

Dizziness

13%

Lower extremity edema

13%

Hypomagnesemia

13%

Hyperglycemia

13%

Hypophosphatemia

13%

Low TSH

13%

Bilateral foot pain

13%

Difficulty with sleep

13%

Monocyte count increase

13%

Mucous discharge

13%

Chloride level increase

13%

Anorexia

13%

Abnormal bowel habits

13%

High TSH

13%

Anal fissure

13%

Carbon Dioxide Decreased

13%

Urinary Urgency

13%

Diarrhea

13%

Hypernatremia

13%

Hyponatremia

13%

Nosebleed

13%

Acute kidney disease

13%

Bladder incontinence

13%

Bowel incontinence

100%

80%

60%

40%

20%

Study treatment Arm

IMPT for Anal Cancer (Single Arm Trial)

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,703 Previous Clinical Trials

40,931,702 Total Patients Enrolled

81 Trials studying Ependymoma

8,832 Patients Enrolled for Ependymoma

M.D. Anderson Cancer CenterLead Sponsor

2,981 Previous Clinical Trials

1,789,683 Total Patients Enrolled

4 Trials studying Ependymoma

36 Patients Enrolled for Ependymoma

David R GrosshansPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy?

"The limited existing data on Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy makes it difficult to assess safety, so our team assigned a score of 1."

Answered by AI

To what extent is the cohort for this research project expanding?

"Indeed, the information hosted by clinicaltrials.gov attests to this study's recruitment status. It was initially posted on April 1st 2019 and last updated on January 13th 2021 with a goal of 48 patients from 2 sites."

Answered by AI

Does this research trial currently accept volunteers?

"Affirmative, clinicaltrials.gov reveals that this trial is in the process of searching for participants. The post was first published on April 1st 2019 and last revised on January 13th 2021. There are 48 openings at two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

2019. "LET Optimized IMPT in Treating Pediatric Patients With Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03750513.

All > Ependymoma