Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Study

Diffuse Midline Glioma, H3 K27M-Mutant Clinical Trial

Official title:

Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077735
• Other study ID #: GMROR2162
• Secondary ID: NCI-2021-1001021
• Status: Recruiting
• Phase: Phase 2
• Start date: October 6, 2021
• Est. completion date: October 15, 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas. This study aims to change the way radiation is delivered, from giving 6 weeks of radiation all at once to giving 2 weeks of radiation. This may determine if there is a difference in the outcome of the treatment, and most importantly, the patients' quality of life.

Description:

PRIMARY OBJECTIVE: I. To estimate the time to progression after the second hypofractionated radiation course of 25 Gy in 10 fractions in patients with diffuse midline glioma of the pons, calculated from date of diagnosis. SECONDARY OBJECTIVES: I. To evaluate the quality of life outcomes for patients with diffuse midline gliomas of the pons. II. To estimate progression free survival intervals for patients after each hypofractionated radiation treatment course. III. To evaluate the quality of life outcomes for parents of patients =< 18 years with the Functional Assessment of Cancer Therapy General (FACT-G) Family/Caregiver Questionnaire. IV. To estimate the overall survival for patients with diffuse midline gliomas of the pons treated with planned multi-course hypofractionated radiation courses. V. To report toxicities associated with hypofractionated, planned, multi-course radiation treatment for diffuse midline glioma of the pons. OUTLINE: Patients undergo hypofractionated radiation therapy (RT) over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo magnetic resonance imaging (MRI) and positron emission tomography- computed tomography (PET-CT) scan throughout the study. After completion of study treatment, patients are followed up at 1 month, every 2 months for year 1, every 3 months for year 2, then every 6 months for year 3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Age >= 1 year(s) old (no maximum age)
• Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of >= 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign)
• If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy
• If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study
• If biopsy has already been completed at an outside institution, the outside pathology report will be reviewed ahead of trial enrollment. The pathology specimen will then be sent to Mayo Clinic for further review, but will not delay study enrollment
• Able to undergo MRI Brain
• Negative urine pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only
• Primary language of English or Spanish for patients and their caregiver
• Patient or caregiver willing and able to provide written informed consent
• Caregiver able to complete questionnaires by themselves or with assistance
• Willing to return to enrolling institution for follow-up during the active monitoring phase of the study

Exclusion Criteria:

• Any patient who has received previous radiation to the brain
• Any patient who has received previous chemotherapy
• Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2)
• Any of the following:
• Pregnant women
• Nursing women
• Women of childbearing potential who are unwilling to employ adequate contraception
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Other active malignancy =< 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix
• NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
• Patients > 16 years with an Eastern Cooperative Oncology Group (ECOG) score >= 4 and patients =< 16 years with a Lansky play scale =< 20

Related Conditions & MeSH terms

• Diffuse Midline Glioma, H3 K27M-Mutant
• Glioma

Intervention

Radiation:
• Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Positron Emission Tomography and Computed Tomography Scan
Undergo PET-CT scan

Locations

Country	Name	City	State
United States	Mayo Clinic Hospital in Arizona	Phoenix	Arizona
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	The Wilcoxon Signed-Rank Tests for Non-Inferiority was utilized from PASS software for this design.	From date of diagnosis to the date of radiographic or clinical progression following second course of hypofractionated radiation therapy, assessed up to 3 years
Secondary	Quality of Life Measurement	Results from Pediatric Quality of Life Inventory Brain Tumor Module will be used to evaluate the quality of life outcomes in patients up to 18 years old and National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (FACT)-Brain Symptom Index-24 in patients more than 18 years old. Changes in raw score from baseline to each time-point will be assessed, in each of the physical and mental health domains. The Wilcoxon signed-rank test will be utilized to assess changes in raw scores. Mean change, along with standard deviation will be reported.	Baseline up to 3 years
Secondary	Progression free survival	The average progression free survival interval after each course of RT will be reported in months.	From registration date to the earliest date of documentation of progression after each course of radiation therapy (RT) or death due to any cause, assessed up to 3 years
Secondary	FACT-General Family/Caregiver Questionnaire	Changes in raw score from baseline to each time-point will be assessed, in each of the physical and mental health domains. The Wilcoxon signed-rank test will be utilized to assess changes in raw scores. Mean change, along with standard deviation will be reported.	Up to 3 years
Secondary	Overall survival	The distribution of overall survival will be estimated using method of Kaplan-Meier.	From registration date to death due to any cause, censoring patients alive at the date of last contact, assessed up to 3 years
Secondary	Incidence of adverse events	The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.	Up to 3 years