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New treatment option for Diffuse Midline Glioma, H3 K27M-Mutant
Official title Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Trial
ClinicalTrials.gov ID: NCT05077735
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- 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...
- 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...
- If biopsy has already been completed at an outside institution, the outside pathology report will be reviewed ahead of trial enrollment. The...
You likely can't join if
- 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
See the full eligibility 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...
- 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 If this cannot be completed, patients will be withdrawn from the study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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.