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Could an arthritis drug help kids with a rare brain tumor?

NCT ID NCT03970226

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.