ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
NCT05233397 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-23
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.
Conditions
- Adamantinomatous Craniopharyngioma
- Recurrent Adamantinomatous Craniopharyngioma
Interventions
- DRUG
-
For \< 30 kg: 12 mg/kg IV every 2 weeks; For ≥30 kg: 8 mg/kg IV every 2 weeks
Sponsors & Collaborators
-
Children's Hospital Colorado
collaborator OTHER -
Nationwide Children's Hospital
lead OTHER
Principal Investigators
-
Holly Lindsay, MD · Children's Hospital Colorado
-
Todd C Hankinson, MD · Children's Hospital Colorado
-
Maryam Fouladi, MD · Nationwide Children's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 39 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-16
- Primary Completion
- 2027-12-31
- Completion
- 2029-12-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
Study Locations
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