RecruitingPhase 2NCT05077735

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

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

Sponsor

Mayo Clinic

Enrollment

29 participants

Start Date

Oct 11, 2021

Study Type

INTERVENTIONAL

Conditions

Diffuse Midline Glioma, H3 K27M-Mutant

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.

Eligibility

Min Age: 1 Year

Inclusion Criteria11

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 If this cannot be completed, patients will be withdrawn from the study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 Criteria12

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