Purpose of this Study
Before joining the main part of the study, you will have some tests to see if you qualify. These tests include check-ups for your body, skin, eyes, and nerves, as well as heart tests, an MRI scan, and bloodwork.
If you qualify, you will have more tests every few cycles. A cycle is 28 days. These tests include check-ups, eye exams, blood tests, a stool sample, and MRI scans.
After the treatment part of the study, you will be in a follow-up study called PNOC COMP. This part will look at how your thinking, daily life, and feelings change over time. You will get a different form to learn more about that part of the study.
Who Can Participate?
Eligibility
To join this study, patients must have a brain tumor called low-grade glioma that has a special gene change called BRAF V600. This must be confirmed by lab tests. They must be older than 12 months and younger than 25 years. The tumor must be something doctors can measure.
There are two groups in the study:
Group 1 is for patients who have not had any treatment yet, except surgery.
Group 2 is for patients whose tumor came back or got worse after treatment. They can join again if they took dabrafenib and trametinib before, did not get worse while on it, and have been off the medicine for at least 6 months.
Patients cannot join if their tumor has certain other gene changes, like IDH, Histone H3, or NF-1.
Age Range
1-24
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The goal of this study is to see how fast brain tumors grow in people with low-grade glioma. It will compare two groups: one group will stop taking the medicines dabrafenib and trametinib, and the other group will slowly take less of the medicines after using them for 12 to 24 months.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 2 De-escalation Study of Dabrafenib and Trametinib for Patients with BRAF V600 Mutant Low-Grade Gliomas
Principal Investigator
Daniel
Landi
Protocol Number
PRO00118465
NCT ID
NCT07110246
Phase
II
Enrollment Status
Open to Enrollment