Spots Global Cancer Trial Database for Study of Ribociclib and Everolimus in HGG and DIPG
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Trial Identification
Brief Title: Study of Ribociclib and Everolimus in HGG and DIPG
Official Title: PhaseII Study of Ribociclib and Everolimus Following Radiotherapy in Pediatric and Young Adult Patients Newly Diagnosed With HGG Including DIPG, Which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways
Study ID: NCT05843253
Study Description
Brief Summary: 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.
Detailed Description: This is a multicenter, international, phase II study of post-radiotherapy (RT) combination of ribociclib and everolimus to treat pediatric, adolescent, and young adult patients newly diagnosed with HGG and DIPG that harbor alterations of the cell cycle and/or PI3K/mTOR pathways to assess treatment efficacy (Part 2). The study will include a feasibility cohort (Part 1) to identify the dose of ribociclib PfOS (Powder for Oral Suspension) that is safe and tolerable in combination with everolimus. Efficacy for Part 2 study will be defined by progression-free survival (PFS; HGG \[stratum A\]) and Overall Survival (OS; DIPG \[stratum B\]), with key longitudinal biomarker correlatives. Outcomes among patients with primary thalamic, spinal cord, and/or secondary (radiation related) HGG (strata C) will be descriptively analyzed. Objective radiographic response rates and agent-specific toxicities will also be assessed, with a feasibility cohort to determine the recommended phase II dose (RP2D) of the combination of ribociclib and everolimus in patients with metastatic disease who received upfront craniospinal irradiation (stratum D). Protocol therapy with the maintenance combination of ribociclib and everolimus must begin no later than 35 calendar days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT. Each cycle will be 28 days in duration and treatment can continue up to a total of 26 cycles. Ribociclib will be given orally once daily for 3 weeks (days 1-21), with one week off. Everolimus will be given orally daily continuously (days 1-28).
Keywords
Eligibility
Minimum Age: 12 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Duke University Health System, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Texas Children's Hospital, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
Queensland Children's Hospital, South Brisbane, Queensland, Australia
Perth Children's Hospital, Perth, Western Australia, Australia
The Hospital for Sick Children (SickKids), Toronto, Ontario, Canada
Montreal Children's Hospital, Montréal, Quebec, Canada
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ), Heidelberg, Baden-Württemberg, Germany
Princess Máxima Center, Utrecht, , Netherlands
Great Ormond Street Hospital, London, , United Kingdom
Contact Details
Name: Margot Lazow, MD
Affiliation: Nationwide Children's Hospital
Role: STUDY_CHAIR
Name: Maryam Fouladi, MD
Affiliation: Nationwide Children's Hospital
Role: PRINCIPAL_INVESTIGATOR
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