LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

NCT03750513 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 2018-0344NCI-2018-02519P30CA016672U19CA021239
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.

Conditions

Anaplastic Ependymoma; Ependymoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  The safety of linear energy transfer-optimized intensity modulated proton therapy will be defined by treatment failures which include imaging changes consistent with necrosis in the presence of Common Terminology Criteria for Adverse Events version 4.03 symptoms of grade 3 brain necrosis and/or local recurrence within the first 6 months from the end of proton therapy.

  Up to 6 months post treatment

Secondary Outcomes (7)

• Identify imaging biomarkers of structural and biological changes after proton therapy

  Up to 24 months post-treatment

• Quantitative image biomarkers

  Up to 24 months post-treatment

• Validity of relative biological effectiveness models

  Up to 24 months post-treatment

• Incidence of late and acute toxicities

  Up to 24 months post treatment

• Progression-free survival

  Up to 24 months post treatment

Study Arms (1)

Treatment (LET optimized IMPT)

EXPERIMENTAL

Patients receive LET optimized IMPT for up to 6 weeks.

Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy RADIATION

Given LET optimized IMPT

Also known as: LET-Optimized IMPT, LET-Optimized Intensity Modulated Proton Therapy, Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT)

Treatment (LET optimized IMPT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (LET optimized IMPT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (LET optimized IMPT)

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III
• Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
• Patient may not receive chemotherapy concurrent with radiation
• Signed informed consent by patient and/or parents or legal guardian
• Lansky performance status score of 50 -100

You may not qualify if:

• Patients with previous radiation therapy to the brain
• Ependymoma of the spine
• Disseminated ependymoma requiring craniospinal radiation therapy
• Pregnancy
• Inability to undergo MR imaging
• Inability to receive gadolinium-based contrast agent

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Ependymoma

Interventions

Linear Energy Transfer

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Energy Transfer; Biophysical Phenomena; Physical Phenomena; Biochemical Phenomena; Chemical Phenomena

Study Officials

• David R Grosshans

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Grosshans

CONTACT

713-563-2300; dgrossha@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 23, 2018
• Study Start: April 1, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

US (2)