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ACTEMRA for Pediatric Craniopharyngioma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 4 trial • 59 Patients • NCT02034474Trial Design
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- My hemoglobin level is above 8 g/dL.I do not have any major health issues that could affect my safety or participation in the study.I had surgery less than 6 weeks ago or am worried about how my surgical wound is healing.I have a history of serious gastrointestinal issues like IBD or a perforated gut.I have not received any live vaccines in the last three months.I do not have any infections that are currently uncontrolled.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.It has been over 3 weeks since my last monoclonal antibody treatment.I have been diagnosed with a specific type of brain tumor known as adamantinomatous craniopharyngioma.I am not pregnant or breastfeeding and agree to use effective birth control.I haven't taken any cancer treatment drugs for at least a week.I have ACP, had surgery, no prior radiation, but maybe other treatments. Progression is okay.You have had allergic reactions to similar medications or substances that are similar to tocilizumab and its ingredients.I do not have a history of HIV, Hepatitis B, Hepatitis C, or Tuberculosis.My kidney function is within the normal range for my gender.I am not currently taking any cancer treatment drugs.My ACP has worsened or returned 6 months after radiation.You have had issues with alcohol, drugs, or chemicals in the past 6 months.I am not currently taking any experimental drugs.I can do most daily activities by myself, even if I use a wheelchair.My bone marrow is working well.My platelet count is above 100,000/mm3 without transfusions for the last 7 days.I am between 1 year and 25 years old.My disease can be measured or seen on tests.I am taking other medications.My last radiation treatment was over 6 months ago, and I've never had craniospinal irradiation.My seizures are under control with medication.My liver is working well.My ACP has worsened or returned 6 months after radiation.I haven't taken any cancer treatment drugs for at least a week.My brain and nerve functions are normal.My organs are functioning well.I am between 12 and 25 years old.I have recovered or stabilized from side effects of my previous treatments.It has been over 42 days since my last immunotherapy treatment.My kidney function is normal.It has been over 6 weeks since my last surgery.My neurological symptoms have been stable for at least a week.My diagnosis is adamantinomatous craniopharyngioma based on tumor or cyst fluid analysis.I have been on a stable or decreasing dose of dexamethasone for at least a week.It has been over 21 days since my last intense chemotherapy.My kidney function, based on my age and gender, is within the normal range.I have ACP, had surgery, no prior radiation, but maybe other treatments. Progression is okay.
- Group 1: Stratum 1 and Stratum 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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