← Back to Search

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

Diagnosis: Patients with histologically-confirmed adamantinomatous craniopharyngioma (ACP) Histologic confirmation of ACP may be made on solid tumor or, if no solid tumor can be safely obtained, cyst fluid with classic ACP characteristics of thick, cholesterol-rich, greenish-brown liquid in the context of imaging features consistent with craniopharyngioma, including lobulated, cystic/solid mass with calcifications that originates in the sellar/suprasellar region.

≥ 16 years: maximum serum creatinine 1.7 mg/dL for males and 1.4 mg/dL for females.

Must not have

Gastrointestinal Disease: Patients with a history of serious gastrointestinal disease, including inflammatory bowel disease or gastrointestinal perforation

Patients who have an uncontrolled infection are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ACTEMRA, a drug that blocks a protein called IL-6, in children with a recurring brain tumor called ACP. The goal is to see if it can reduce tumor growth and improve their quality of life.

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.

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.

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

Select...

I have been diagnosed with a specific type of brain tumor known as adamantinomatous craniopharyngioma.

Select...

My kidney function is within the normal range for my gender.

Select...

I am between 1 year and 25 years old.

Select...

My disease can be measured or seen on tests.

Select...

My last radiation treatment was over 6 months ago, and I've never had craniospinal irradiation.

Select...

I am between 12 and 25 years old.

Select...

It has been over 42 days since my last immunotherapy treatment.

Select...

It has been over 6 weeks since my last surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of serious gastrointestinal issues like IBD or a perforated gut.

Select...

I do not have any infections that are currently uncontrolled.

Select...

I do not have a history of HIV, Hepatitis B, Hepatitis C, or Tuberculosis.

Select...

I am not currently taking any cancer treatment drugs.

Select...

I am not currently taking any experimental drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

nausea

agranulocytosis

Inpatient admission

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tocilizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met