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Monoclonal Antibodies

Tocilizumab for Craniopharyngioma

Phase < 1
Recruiting
Led By Kathleen Dorris, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Adequate renal function defined as:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of study to end of study, up to 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment. Patients with new or recurrent/ progressed craniopharyngioma tumors will be given tocilizumab, a drug that may help shrink the tumor. The study will be conducted in two phases, and patients will be followed for up to 5 years.

Who is the study for?
This trial is for children and young adults (2 to <21 years old) with a type of brain tumor called craniopharyngioma. It's open to those with new, recurrent, or progressive tumors that haven't been fully removed by surgery or have come back after treatment. Participants need functioning major organs and acceptable blood counts, must not be pregnant or breastfeeding, and should agree to use birth control.Check my eligibility
What is being tested?
The study tests Tocilizumab in two phases: Phase 0 checks if the drug reaches the tumor when given before standard surgery. If successful, Phase 1 gives Tocilizumab every two weeks for up to a year to see how well it works as a treatment. Patients can move from Phase 0 to Phase 1 and will be monitored for five years.See study design
What are the potential side effects?
Tocilizumab may cause allergic reactions in some individuals who are sensitive to it. Other potential side effects include increased risk of infection due to immune system suppression, liver function changes, and abnormal blood counts which could lead to bleeding issues or increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, based on my age and gender, meets the required levels.
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My kidney function is normal.
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My ACP has come back or gotten worse after surgery and radiation.
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My doctor plans to remove or test a part of my tumor for my treatment.
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My doctors think I have a brain tumor called craniopharyngioma based on my scans.
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My liver is working well.
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My cancer has grown or changed after treatment, as confirmed by my doctor.
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My child is active and can do most activities without help.
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I am between 2 and 20 years old.
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I have previously been treated with tocilizumab or other IL6 inhibitors.
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My previously confirmed ACP has gotten worse or come back.
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My ACP came back or got worse after surgery without radiation.
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I am able to care for myself and perform daily activities.
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My liver tests are within normal limits for my age.
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My bone marrow is working well.
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My organs are functioning well.
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I am over 16 and can care for myself but may not be able to do active work.
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I have a newly diagnosed ACP that can't be fully removed and is measurable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of study to end of study, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of study to end of study, up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility Phase: Toxicity Profile
Phase 0: Presence of Tocilizumab and Metabolites
Secondary outcome measures
Feasibility Phase: 1-Year Disease Stabilization
Feasibility Phase: Cytokines
Feasibility Phase: Immunity
+4 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

2Treatment groups
Experimental Treatment
Group I: Tocilizumab Administration: Phase 0Experimental Treatment1 Intervention
In Phase 0, patients will receive one dose of tocilizumab prior to surgery.
Group II: Tocilizumab Administration: Feasibility PhaseExperimental Treatment1 Intervention
During the Feasibility Phase, patients will receive tocilizumab every 2 weeks for up to 13 cycles (approximately 1 year). Patients will be followed for up to 5 years.
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?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,521 Total Patients Enrolled
1 Trials studying Craniopharyngioma
250 Patients Enrolled for Craniopharyngioma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,126 Total Patients Enrolled
17 Trials studying Craniopharyngioma
2,004 Patients Enrolled for Craniopharyngioma
Kathleen Dorris, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

Tocilizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03970226 — Phase < 1
Craniopharyngioma Research Study Groups: Tocilizumab Administration: Feasibility Phase, Tocilizumab Administration: Phase 0
Craniopharyngioma Clinical Trial 2023: Tocilizumab Highlights & Side Effects. Trial Name: NCT03970226 — Phase < 1
Tocilizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03970226 — Phase < 1

Frequently Asked Questions

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

Does this trial extend to individuals past the age of eighty?

"To be eligible for this trial, participants must have an age ranging from 2 years to 21 years. There are 18 studies available to those younger than 18 and 67 studies allocated for individuals over 65."

Answered by AI

Who is eligible to join the experiment?

"This clinical trial is seeking roughly 27 participants who have adamantinous craniopharyngioma, aged between 2 and 21 years old."

Answered by AI

For what is Tocilizumab commonly prescribed as a remedy?

"Tocilizumab can be used to address polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis (sjia), and the cytokine release syndrome commonly associated with chimeric antigen receptor T-cell therapy."

Answered by AI

Are there any additional investigations involving Tocilizumab?

"Currently, Tocilizumab is being investigated in a total of 71 clinical trials, with 8 of them currently in Phase 3. While many studies are conducted out of Poznan and New york City, 1455 medical centres around the globe have registered to run research into this drug."

Answered by AI

Could you summarize the major goals of this trial?

"This long-term study has one primary objective: to measure the presence of Tocilizumab and its metabolites. There are also three secondary objectives, which include determining cytokine signaling in tumor tissue or cyst fluid using ELISA, gauging overall response rate with radiography for newly diagnosed ACP cases given systemic tocilizumab therapy, and demonstrating immune cell infiltration in tumor tissues via immunohistochemistry and flow cytometry."

Answered by AI

Are there any current opportunities for individuals to join this trial?

"Clinicaltrials.gov suggests that enrollment is still open for this medical investigation, which was first posted on June 27th 2019 and subsequently edited on May 16th 2022."

Answered by AI

How many individuals are being given the opportunity to participate in this trial?

"Affirmative. According to clinicaltrials.gov, this trial became available on June 27th 2019 and is currently enrolling participants. To date, the study has identified 1 site for recruitment and needs to fill in 27 spots."

Answered by AI
~3 spots leftby Dec 2024