Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG/DIPG Which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant
This study is testing two new drug combinations to see if they can help stop or slow down the growth of aggressive brain and spinal cord tumors in children and young adults. The goal is to see if these treatments can help patients live longer by targeting specific genetic changes that help the cancer grow.
This trial is for patients aged 1 to 39 with a newly diagnosed, fast-growing brain tumor (known as high-grade glioma or DIPG). Eligibility depends on the specific genetic makeup of the tumor, which will be confirmed through lab testing of a tissue sample.
Participants will receive a combination of medications—either ribociclib with everolimus or ribociclib with temozolomide—after they have finished radiation therapy. You will be closely monitored by your medical team throughout the study to track how the treatment is working and manage any side effects.
The study is currently recruiting patients at medical centers in Aurora, Colorado; Washington, D.C.; and Chicago, Illinois. If you are interested, your doctor can help you determine if one of these locations is right for you.
- 1Tests new drug combinations for aggressive brain and spinal cord tumors.
- 2Specifically targets tumors with certain genetic traits to block cancer growth.
- 3Requires confirmation of tumor type through a biopsy or surgery sample.
- 4Participants must agree to use highly effective birth control during and shortly after the treatment.
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