LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 1

Conditions: Ependymoma; Anaplastic Ependymoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03750513

P30CA016672 (U.S. NIH Grant/Contract)

2018-0344 (Other Identifier)

U19CA021239 (U.S. NIH Grant/Contract)

NCI-2018-02519 (Registry Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 48 estimated patients

Sex: All

Ages: Under 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Treatment (LET optimized IMPT)

Experimental group

Description:

Patients receive LET optimized IMPT for up to 6 weeks.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy