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LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

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ClinicalTrials.gov Identifier: NCT03750513
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : January 14, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anaplastic Ependymoma Ependymoma Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 1

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.

Study Design
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Study Type : Interventional
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (LET optimized IMPT)
Patients receive LET optimized IMPT for up to 6 weeks.
 Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Given LET optimized IMPT
Other Names:
  • LET-Optimized IMPT
  • LET-Optimized Intensity Modulated Proton Therapy
  • Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT)

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Quantitative image biomarkers [ Time Frame: Up to 24 months post-treatment ]
    Descriptive statistics will be used to summarize the study data.

  3. Validity of relative biological effectiveness models [ Time Frame: Up to 24 months post-treatment ]
    Descriptive statistics will be used to summarize the study data.

  4. 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.

  5. Progression-free survival [ Time Frame: Up to 24 months post treatment ]
    The method of Kaplan and Meier will be used to provide estimates.

  6. Overall survival [ Time Frame: Up to 24 months post treatment ]
    The method of Kaplan and Meier will be used to provide estimates.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750513


Contacts
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Contact: David Grosshans 713-563-2300 dgrossha@mdanderson.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Tristin Flood       TEFLOOD@mgh.harvard.edu   
Principal Investigator: Shannon M. MacDonald         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: David R. Grosshans    713-563-2300      
Principal Investigator: David R. Grosshans         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David R Grosshans M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03750513    
Other Study ID Numbers: 2018-0344
NCI-2018-02519 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0344 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
U19CA021239 ( U.S. NIH Grant/Contract )
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ependymoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue