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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year and Over
Gender All
More 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If this cannot be completed, patients will be withdrawn from the study.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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05077735
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anita Mahajan, M.D.
Principal Investigator Affiliation Mayo Clinic in Rochester
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Diffuse Midline Glioma, H3 K27M-Mutant
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

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 PET-CT scan throughout the study.

Interventions

Radiation: - Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Other: - Questionnaire Administration

Ancillary studies

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Procedure: - Positron Emission Tomography and Computed Tomography Scan

Undergo PET-CT scan

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Hospital in Arizona, Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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