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Immunotherapy for Pediatric Liver Cancer
Study Summary
This trial is testing an immunotherapy drug to see if it can treat pediatric liver cancer.
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 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I am older than 16 years.I haven't had any cancer treatment in the last 14 days.My organ and bone marrow functions are normal.My thyroid function is normal.My insurance has approved the use of Pembrolizumab for my treatment.My kidney function, measured by creatinine levels, is within the normal range for my age and gender.I have recovered from side effects of my previous cancer treatments.I am not taking any anti-inflammatory or immunosuppressive medications.My liver cancer has returned or didn't respond to treatment.My kidney function, based on my age and gender, is within the required range.My kidney function is normal.My child is between 2 and less than 6 years old.I haven't had radiotherapy in the last week and have recovered from any side effects.My bone marrow is working well.I have a tumor that can be measured by scans or physical exam.I have never tested positive for HIV/AIDS.My thyroid function is normal or controlled with medication.I can provide a tumor sample for testing.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am between 10 and less than 13 years old.This criterion does not apply to me.I am younger than 30 years old.I haven't had antibody therapy recently.I am not on long-term steroids exceeding the specified doses.I have not taken any PD-1, PD-L1, or CTLA-4 inhibitors.My kidney function is good, with a creatinine clearance rate of 60 mL/min or higher.My liver is working well.I am between 6 and 9 years old.I am mostly able to care for myself and carry out daily activities.I am between 13 and less than 16 years old.You have had severe allergic reactions to drugs similar to pembrolizumab, or you have had a serious allergic reaction to other monoclonal antibody treatments.
- Group 1: Pembrolizumab
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Might I be eligible to take part in this research project?
"This trial is seeking 18 participants who have hepatocellular carcinoma, and who were diagnosed with the condition in childhood. Those that wish to join should be between 0 and 30 years old."
What condition has seen the greatest improvement with Pembrolizumab?
"Pembrolizumab is an effective treatment for malignant neoplasms, unresectable melanoma, and microsatellite instability high."
At how many different locations is this trial currently taking place?
"Presently, there are 5 sites where this study is taking place: Baylor College of Medicine (Houston), Dana Farber Cancer Institute (Boston), Children's Hospital Boston (Cincinnati), and other locations."
What are Pembrolizumab's long-term effects on patients?
"Pembrolizumab has received a Phase 2 rating, meaning that while there is some evidence suggesting it is safe, there is no data to support its efficacy. Consequently, our team at Power have given it a safety score of 2."
How many people are allowed to enroll in this research project?
"In order to properly run this trial, 18 willing and eligible participants are required. These individuals can visit either of the two main study locations - Baylor College of Medicine in Houston or Dana-Farber Cancer Institute in Boston - though other recruitment sites may be available."
What other studies has Pembrolizumab been a part of in the past?
"City of Hope conducted the first clinical trial for pembrolizumab in 2010 and there are now 249 completed studies. Out of the 1000+ trials currently underway, many are being performed in Houston, Texas."
Are there any positions available for participants in this research project?
"Yes, this trial is still recruiting patients according to the most recent update on clinicaltrials.gov from September 8th, 2020. The study was first posted on November 1st, 2020."
Can patients below the age of 45 years old participate in this research?
"According to the inclusion criteria for this trial, qualified applicants are aged 0 to 30. There are currently 126 studies recruiting patients under 18 and 3813 for people over 65."
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