New radiation therapy approach for diffuse midline glioma
Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)
This study is testing a new way of giving radiation therapy in fewer sessions to see if it helps people with diffuse midline gliomas live longer and have a better quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Trial ID | NCT05077735 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of hypofractionated radiation therapy in patients with diffuse midline gliomas, specifically targeting the pons. The study aims to deliver radiation in a split-course format over 10 fractions instead of the traditional 30 fractions over 6 weeks. Primary objectives include assessing the 10-month overall survival rate and evaluating quality of life outcomes for both patients and their caregivers. Patients will undergo MRI and PET scans to monitor treatment response and progression.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 1 year and older diagnosed with diffuse midline glioma of the pons who meet specific radiologic criteria.
Not a fit: Patients without the required radiologic features or those unable to undergo a biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with diffuse midline glioma.
How similar studies have performed: While hypofractionated radiation therapy is a novel approach for this specific condition, similar strategies have shown promise in other cancer treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Phoenix, Arizona and 1 other locations
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Roman O. Kowalchuk, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.