Actively Recruiting

Phase 2
Age: 1Year - 39Years
All Genders
NCT05233397

ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Led by Nationwide Children's Hospital · Updated on 2026-04-23

30

Participants Needed

14

Research Sites

363 weeks

Total Duration

On this page

Sponsors

N

Nationwide Children's Hospital

Lead Sponsor

C

Children's Hospital Colorado

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Who Can Participate

Age: 1Year - 39Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 12 months and 39 years at enrollment
  • Histologically confirmed adamantinomatous craniopharyngioma diagnosis
  • Measurable disease present
  • Stratum 1: Progressive or recurrent ACP at least 6 months after radiation therapy
  • Karnofsky score 250% for patients older than 16 years; Lansky score 250 for patients 16 years or younger
  • Stable neurological deficits for at least 7 days before enrollment
  • Recovery or stabilization from prior acute treatment toxic effects
  • Adequate bone marrow, kidney, liver, and neurological function
  • Signed informed consent by patient or legal representative
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Lack of effective contraception for patients of reproductive potential
  • History of serious gastrointestinal disease, including inflammatory bowel disease or perforation
  • Unstable corticosteroid use or currently receiving other investigational or anti-cancer drugs
  • Uncontrolled infections or recent live/attenuated vaccinations within 3 months
  • Significant concurrent medical or surgical conditions jeopardizing safety
  • History of HIV, Hepatitis B or C, Tuberculosis, or prior solid organ transplant
  • Inability to comply with safety monitoring
  • History of alcohol, drug, or chemical abuse within 6 months
  • Major or intermediate surgery within last 6 weeks or poor wound healing concerns
  • Allergic reactions to tocilizumab or similar compounds

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 14 locations

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

2

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

3

Nicklaus Children's Hospital

Miami, Florida, United States, 33155

Active, Not Recruiting

4

Duke Children's Hospital

Durham, North Carolina, United States, 27710

Actively Recruiting

5

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

6

Nationwide Children's Hospital

Columbus, Ohio, United States, 43235

Actively Recruiting

7

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

8

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

9

Sydney Children's Hospital

Randwick, New South Wales, Australia, 2031

Actively Recruiting

10

Queensland Children's Hospital

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

11

Perth Children's Hospital

Perth, Western Australia, Australia, 6000

Actively Recruiting

12

Stollery Children's Hospital

Edmonton, Alberta, Canada, T6G2B7

Actively Recruiting

13

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada, M5G1X8

Actively Recruiting

14

McGill University Health Center

Montreal, Quebec, Canada

Actively Recruiting

Loading map...

Research Team

K

Kelsey H Troyer, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here