Purpose of this Study
People in this study will visit the research center two times each month to see the study doctor. The study can last up to 2 years. Treatment happens in cycles, and each cycle is 28 days long, which is about 4 weeks. A person can have up to 26 cycles, which equals about 2 years of treatment. The amount of medicine given will depend on the person’s weight, which is checked before each new cycle. The medicine is called tocilizumab. It blocks a protein called interleukin-6, which causes swelling in the body. This medicine is usually used for diseases where the immune system attacks the body, like arthritis, and it can also help with a problem called cytokine release syndrome after certain cancer treatments.
Who Can Participate?
Eligibility
Age: Patients must be at least 1 year old and no older than 39 years when they join.
Diagnosis: Patients must have a confirmed diagnosis of adamantinomatous craniopharyngioma (ACP).
This can be proven by looking at tumor tissue under a microscope.
If tissue cannot be safely taken, doctors may test cyst fluid. ACP cyst fluid is usually thick, cholesterol‑rich, and greenish‑brown.
Imaging scans should show a lobulated mass (part solid, part cystic) with calcifications in the sellar/suprasellar region of the brain.
Disease Status: Patients must have a tumor that can be measured on scans.
Age Range
1-39
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to learn how a medicine called tocilizumab works for people who have a brain tumor called Adamantinomatous craniopharyngioma, or ACP. Doctors will check both the good effects and the bad effects of the medicine.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
CONNECT1905: Phase 2 Study of Systemic IL-6 Receptor Antagonist ACTEMRA® (tocilizumab) for the treatment of Progressive/Recurrent Pediatric Adamantinomatous Craniopharyngioma
Principal Investigator
Daniel
Landi
Protocol Number
PRO00113161
NCT ID
NCT05233397
Phase
II
Enrollment Status
Open to Enrollment