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IL-6 receptor antagonist

ACTEMRA for Pediatric Craniopharyngioma

Phase 2
Recruiting
Led By Maryam Fouladi, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hemoglobin >8 g/dL (may be transfused)
Monoclonal antibodies: At least 21 days after the last dose of a monoclonal antibody.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test the use of ACTEMRA to treat kids with a rare brain tumor who have already had surgery and/or radiation.

Who is the study for?
This trial is for children and young adults aged between 1 to 25 years with confirmed adamantinomatous craniopharyngioma, a type of brain tumor. They must have measurable disease, be stable post-surgery or radiation therapy, and not have received certain treatments recently. Patients with controlled seizures can join but those with uncontrolled infections or recent vaccinations cannot.Check my eligibility
What is being tested?
The study tests ACTEMRA (tocilizumab), an IL-6 receptor antagonist already used in arthritis, on pediatric patients who've had surgery and/or radiation for recurrent adamantinomatous craniopharyngioma. It's a Phase II trial to see how effective this drug is in treating this specific brain tumor.See study design
What are the potential side effects?
Tocilizumab may cause side effects like infections due to immune system suppression, infusion reactions similar to allergic responses during the drug administration process, liver enzyme elevations indicating potential liver injury, and gastrointestinal perforation which is a rare but serious condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hemoglobin level is above 8 g/dL.
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It has been over 3 weeks since my last monoclonal antibody treatment.
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I have been diagnosed with a specific type of brain tumor known as adamantinomatous craniopharyngioma.
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I haven't taken any cancer treatment drugs for at least a week.
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I have ACP, had surgery, no prior radiation, but maybe other treatments. Progression is okay.
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My kidney function is within the normal range for my gender.
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My ACP has worsened or returned 6 months after radiation.
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I can do most daily activities by myself, even if I use a wheelchair.
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My bone marrow is working well.
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My platelet count is above 100,000/mm3 without transfusions for the last 7 days.
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I am between 1 year and 25 years old.
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My disease can be measured or seen on tests.
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My last radiation treatment was over 6 months ago, and I've never had craniospinal irradiation.
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My seizures are under control with medication.
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My liver is working well.
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My ACP has worsened or returned 6 months after radiation.
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I haven't taken any cancer treatment drugs for at least a week.
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My brain and nerve functions are normal.
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My organs are functioning well.
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I am between 12 and 25 years old.
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I have recovered or stabilized from side effects of my previous treatments.
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It has been over 42 days since my last immunotherapy treatment.
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My kidney function is normal.
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It has been over 6 weeks since my last surgery.
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My neurological symptoms have been stable for at least a week.
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My diagnosis is adamantinomatous craniopharyngioma based on tumor or cyst fluid analysis.
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I have been on a stable or decreasing dose of dexamethasone for at least a week.
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It has been over 21 days since my last intense chemotherapy.
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My kidney function, based on my age and gender, is within the normal range.
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I have ACP, had surgery, no prior radiation, but maybe other treatments. Progression is okay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sustained objective response rate of patients with measurable ACP who have undergone surgery but have not been previously treated with radiation to treatment with systemic tocilizumab
Sustained objective response rate of patients with recurrent/progressive previously irradiated ACP to treatment with systemic tocilizumab
Secondary outcome measures
Biological effects of tocilizumab on ACP tumor tissue and cyst fluid.
PFS of ACP patients treated with tocilizumab after radiation
PFS of ACP patients treated with tocilizumab who have not received radiation
+1 more

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474
11%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stratum 1 and Stratum 2Experimental Treatment1 Intervention
Stratum 1: Patients with progressive or recurrent adamantinomatous craniopharyngiomas following radiation therapy. Stratum 2: Patients with measurable adamantinomatous craniopharyngioma who have undergone surgery but have not previously received radiation therapy. Progressive disease is allowed but not required
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
338 Previous Clinical Trials
5,220,108 Total Patients Enrolled
1 Trials studying Craniopharyngioma
38 Patients Enrolled for Craniopharyngioma
Children's Hospital ColoradoOTHER
114 Previous Clinical Trials
5,127,497 Total Patients Enrolled
1 Trials studying Craniopharyngioma
38 Patients Enrolled for Craniopharyngioma
Maryam Fouladi, MDPrincipal InvestigatorNationwide Children's Hospital
11 Previous Clinical Trials
2,432 Total Patients Enrolled

Media Library

Tocilizumab (IL-6 receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05233397 — Phase 2
Craniopharyngioma Research Study Groups: Stratum 1 and Stratum 2
Craniopharyngioma Clinical Trial 2023: Tocilizumab Highlights & Side Effects. Trial Name: NCT05233397 — Phase 2
Tocilizumab (IL-6 receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233397 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are participating in this clinical trial?

"Presently, this trial is open to patients at Duke University Health System, Cincinnati Children's Hospital Medical Center, Seattle Children's Hospital, and a total of 12 other hospitals."

Answered by AI

Can young adults between the ages of 18 and 29 participate in this research?

"For this particular clinical trial, only individuals aged 1 year to 25 are eligible. Out of the 12 total clinical trials, 9 are for patients under 18 years old and 3 recruit adults over 65."

Answered by AI

Are new participants still being accepted for this trial?

"This particular clinical trial, which was created on November 30th 2022, is not presently recruiting patients. That being said, there are 11 other trials that potential participants could look into."

Answered by AI

What are the goals of this research?

"The primary goal of this 24-month study is to observe the efficacy of tocilizumab in patients with radiation-resistant ACP. Secondary objectives include observing one-year progression-free survival rates for (1) patients that have not received radiation and (2) those that have, as well as measuring the concentration of certain biomarkers in tumor tissue, cyst fluid, or blood."

Answered by AI

Does Tocilizumab have a good safety profile for human use?

"While there is some evidence to support the safety of Tocilizumab, it only received a score of 2 because this is a Phase 2 trial and no efficacy data has been collected yet."

Answered by AI

How can I sign up to participate in this research?

"Eligible patients for this clinical trial must have adamantinous craniopharyngioma and be between 1 year old to 25 years old. In total, the study will allow 38 participants."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~13 spots leftby Dec 2024