LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

Overview

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.

Full Title of Study: “Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2027

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma. SECONDARY OBJECTIVES: I. To utilize advanced multiparametric magnetic resonance (MR) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients. II. To compare quantitative image biomarkers in patients treated with bio-IMPT and standard proton therapy using a voxel level analysis. III. To test and evaluate the validity of relative biological effectiveness (RBE) models and enhance their precision based on prospectively collected clinical image biomarkers. IV. To evaluate acute and late toxicities, including pseudoprogression and symptom burden, in patients treated with bio-IMPT. V. To estimate progression-free survival (PFS) and overall survival (OS). VI. To evaluate disease outcomes following the use of a simultaneous integrated boost (SIB) for pediatric ependymoma patients with gross residual disease following surgery. OUTLINE: Patients receive LET optimized IMPT for up to 6 weeks. After completion of study treatment, patients are followed up at 1 month, then every 3 months for up to 24 months.

Interventions

  • Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
    • Given LET optimized IMPT
  • Other: Quality-of-Life Assessment
    • Ancillary studies
  • Other: Questionnaire Administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: Treatment (LET optimized IMPT)
    • Patients receive LET optimized IMPT for up to 6 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse events
    • Time Frame: Up to 6 months post treatment
    • 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.

Secondary Measures

  • Identify imaging biomarkers of structural and biological changes after proton therapy
    • Time Frame: Up to 24 months post-treatment
    • Descriptive statistics will be used to summarize the study data.
  • Quantitative image biomarkers
    • Time Frame: Up to 24 months post-treatment
    • Descriptive statistics will be used to summarize the study data.
  • Validity of relative biological effectiveness models
    • Time Frame: Up to 24 months post-treatment
    • Descriptive statistics will be used to summarize the study data.
  • Incidence of late and acute toxicities
    • Time Frame: Up to 24 months post treatment
    • Descriptive statistics will be used to summarize the study data. For each study cohort, we will tabulate treatment- failures and other relevant clinically-related features. Interval estimates for proportions will be provided using exact 95% confidence intervals.
  • Progression-free survival
    • Time Frame: Up to 24 months post treatment
    • The method of Kaplan and Meier will be used to provide estimates.
  • Overall survival
    • Time Frame: Up to 24 months post treatment
    • The method of Kaplan and Meier will be used to provide estimates.
  • Disease outcomes following the use of a simultaneous integrated boost
    • Time Frame: Up to 24 months post-treatment
    • Descriptive statistics will be used to summarize the study data.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 22 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David R Grosshans, Principal Investigator, M.D. Anderson Cancer Center
  • Overall Contact(s)
    • David Grosshans, 713-563-2300, dgrossha@mdanderson.org

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