Spots Global Cancer Trial Database for ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
Official Title: Phase 2 Study of Systemic IL-6 Receptor Antagonist ACTEMRA® (Tocilizumab) for the Treatment of Progressive/Recurrent Pediatric Adamantinomatous Craniopharyngioma
Study ID: NCT05233397
Interventions
Study Description
Brief Summary: ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.
Detailed Description: Adamantinomatous Craniopharyngioma (ACP) is a highly debilitating pediatric brain tumor that lacks medical anti-tumor therapies. Current therapy, which depends largely on surgery and radiation, is associated with poor quality of life and becomes more challenging and risky in the setting of recurrent disease. Recent discoveries regarding the biological characteristics of ACP indicate that available agents, including IL-6 pathway blockers may have efficacy in the control of ACP. We hypothesize that the IL6- receptor antagonist ACTEMRA (tocilizumab) will be safe and effective at inducing tumor response in children with residual ACP. In this study, up to 38 patients will receive tocilizumab at the dose approved for pediatric Systemic Juvenile Idiopathic Arthritis (\< 30 kg: 12 mg/kg IV every 2 weeks; ≥30 kg: 8 mg/kg IV every 2 weeks). Therapy may continue for up to two years (26 cycles). It will be a multi-center Phase 2 trial with two strata for patients aged \>1 year and \<25 years with unresectable ACP who may have been previously treated with radiation (Stratum 1, 18 patients) or without radiation (Stratum 2, 18 patients).
Keywords
Eligibility
Minimum Age: 1 Year
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
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
Jasper van der Lugt, Utrecht, , Netherlands
Great Ormond Street Hospital, London, , United Kingdom
Contact Details
Name: Kathleen H Dorris, MD
Affiliation: Children's Hospital Colorado
Role: STUDY_CHAIR
Name: Todd C Hankinson, MD
Affiliation: Children's Hospital Colorado
Role: STUDY_CHAIR
Name: Maryam Fouladi, MD
Affiliation: Nationwide Children's Hospital
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
