Could an arthritis drug help kids with a rare brain tumor?
NCT ID NCT03970226
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called tocilizumab in children with a rare brain tumor called adamantinomatous craniopharyngioma. First, a small group gets one dose before surgery to see if the drug reaches the tumor. If it does, more children will receive the drug every two weeks for about a year to check safety and see if it helps control the tumor. The goal is to find a new way to manage this tumor without relying only on surgery or radiation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Sep 2019
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
2 to 21 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Phase 0 Eligibility: 1. Tumor biopsy/resection and/or cyst aspiration planned for the clinical care of the patient independent of study participation by the treating pediatric neurosurgeon and neuro-oncologist 2. Must meet one of the following criteria: 1. Presumed craniopharyngioma based on imaging features and best judgement of treating medical team (if newly diagnosed) 2. Previous histologically confirmed ACP that has progressed or recurred at the time of enrollment Feasibility Eligibility: 1. Must meet one of the following criteria: 1. Recurrent or progressive\* ACP treated with surgery alone without radiation 2. Recurrent or progressive\* ACP treated with surgery and radiation \* Progressive disease for eligibility purposes will be defined as follows: Solid disease: any growth deemed progression based on discretion of the investigator regardless of timing from RT Cystic disease: must be at least 6 months from last day of RT. Patients demonstrating isolated cyst growth \>6 months after RT must show a continued increase in the cystic component on two serial MRI scans performed at least 4 weeks apart OR at least partial reaccumulation of the cyst following one or more cyst aspirations. 3. Newly diagnosed, by histology or imaging ACP with unresectable residual cystic and/or solid disease that is measurable in 2 dimensions 2. Subjects who participated in the Phase 0 portion and meet eligibility, may enroll in the Feasibility Phase of the study once open. Overall Study Inclusion Criteria: 1. Age: ≥ 2 years and \< 21 years 2. Subjects may have received prior tocilizumab or other IL6 or IL6R inhibitor 3. Organ Function Requirements 1. Adequate bone marrow function defined as: * Platelet count ≥100,000/μl (transfusion independent) * Absolute neutrophil count (ANC) ≥1500/μl 2. Adequate renal function defined as: * Creatinine clearance or radioisotope GFR ≥70 ml/min/1.73 m2 or * A serum creatinine based on age/gender as follows: (Age, Male, Female) 3 to \< 6 years, 0.8, 0.8; 6 to \< 10 years, 1, 1; 10 to \< 13 years, 1.2, 1.2; 13 to \< 16 years, 1.5, 1.4; 16 years to \< 18 years, 1.7, 1.4 3. Adequate liver function defined as: * SGOT (AST) and SGPT (ALT) \<1.5x ULN for age 4. Subjects must meet one of the following performance scores: 1. ECOG performance status scores of 0, 1, or 2; 2. Karnofsky score of ≥60 for patients \> 16 years of age; or 3. Lansky score of ≥60 for patients ≤16 years of age 5. Subjects of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study. 6. Informed consent and assent obtained as appropriate. Exclusion Criteria 1. Pregnant or breastfeeding 2. Uncontrolled intercurrent illness including, but not limited to: 1. ongoing or active infection (including active tuberculosis) 2. symptomatic congestive heart failure 3. unstable angina pectoris 4. cardiac arrhythmia 5. psychiatric illness/social situations that would limit compliance with study requirements are not eligible. 3. Known hypersensitivity or history of anaphylaxis to tocilizumab 4. Received any live vaccinations within 3 months prior to start of therapy 5. Evidence of metastatic disease or other cancer 6. Inability to return for follow up visits or obtain required follow-up studies to assess toxicity of therapy
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adamantinomatous craniopharyngioma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.