Researchers Studying Two Oral Drugs Given After Radiotherapy to Patients Just Diagnosed With High-Grade Glioma (HGG), including DIPG
Phase: Recruiting
First Posted: August
Condition(s): High Grade Glioma (HGG), Diffuse Intrinsic Pontine Glioma (DIPG), Anaplastic Astrocytoma, Glioblastoma, Glioblastoma Multiforme, Diffuse Midline Glioma H3 K27M-Mutant, Metastatic Brain Tumor, WHO Grade III Glioma, WHO Grade IV Glioma
NCT Number: NCT05843253 Other Study ID Number(s): CONNECT TarGeT-A
What Is the Purpose of This Study?
The goal of this study is to determine the efficacy of the study drugs ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target. The main question the study aims to answer is whether the combination of ribociclib and everolimus can prolong the life of patients diagnosed with HGG, including DIPG.
Who Can Take Part in This Study?
People who may be eligible for this study:
- Are aged 12 months to </= 39 years with newly diagnosed HGG, including DIPG/DMG with tissue from biopsy/resection.
- Must enroll on TarGeT-SCR to undergo screening and arm assignment as the first step. Patients are encouraged to enroll in TarGeT-SCR as early as possible, but patients can enroll on TarGeT-SCR up to 21 days post completion of radiation.
- Must (even if enrolling on an arm post-radiation, including TarGeT-A) start radiation within 31 days of definitive surgery.
- Enrollment and treatment on TarGeT-A must begin within 35 days post completion of radiation.
For a full list of eligibility requirements, visit https://www.clinicaltrials.gov/study/NCT05843253
What Will Happen During This Study?
- Ribociclib is taken orally (by mouth) once a day for 21 days in a row, followed by a 7-day break. This cycle repeats every 28 days
- Everolimus is taken orally once a day for 28 days without a break. This cycle repeats every 28 days
Principal Investigator
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Neuro-Oncology
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High-Grade Gliomas
High-grade gliomas are fast-growing cancers that form in the brain or spinal cord. Surgery, radiation, and targeted therapies can help. High-grade gliomas are more aggressive and can grow quickly. They are the second most common type of malignant brain tumor in children.
Brain Tumors
Brain tumors are the most common solid tumors in children. Primary brain tumors start in the brain and usually do not spread outside the brain tissue.