Recruiting
Phase 2

Stereotactic Biopsy

Sponsor:

Mayo Clinic

Code:

NCT05077735

Conditions

Diffuse Midline Glioma, H3 K27M-Mutant

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated Radiation Therapy

Questionnaire Administration

Magnetic Resonance Imaging

Computed Tomography Scan

Study Details

Brief 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.

Conditions

Diffuse Midline Glioma, H3 K27M-Mutant

Study ID

NCT05077735

Start date

Oct 11, 2021

Status verified date

Jul, 2026

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Oct 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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 If this cannot be completed, patients will be withdrawn from the study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

  • NOTE: All novel therapeutic interventions, including but not limited to dordaviprone, are allowed for patients who enroll on the clinical trial

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (hypofractionated RT)

Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and CT scan throughout the study.

Interventions

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Questionnaire Administration

Ancillary studies

Magnetic Resonance Imaging

Undergo MRI

Computed Tomography Scan

Undergo CT scan

Primary outcome measure

  • Time to progression [ Time Frame: At 10 months ]
  • Overall Survival (OS) at 10 months [ Time Frame: Up to 6 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic Hospital in Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Safia K. Ahmed, M.D.

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Roman O. Kowalchuk, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • DIPG
  • H3K27M
  • DMG
  • Diffuse Midline Glioma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-14.