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Pembrolizumab for Pediatric Brain Cancer
Study Summary
This trial is testing pembrolizumab to treat brain tumors in children. The side effects and best dose will be studied, as well as how well it works.
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 don't have an active autoimmune disease needing ongoing steroids or immunosuppressants.I am willing to take steroids for short periods if needed for side effects.I agree to use two forms of birth control or abstain from sex for 4 months after the last dose.I am not currently on any cancer treatment or experimental drugs.My DIPG has not improved or has worsened after radiation therapy.I have or had lung inflammation or significant lung disease.I have a brain tumor with a high mutation rate, including conditions like CMMRD or Lynch syndrome.I have multiple areas of disease in the organs of my body.I am between 1 and 18 years old for the safety part, or under 22 for the efficacy part of the study.I received my last cancer treatment affecting my bone marrow 3 weeks ago, or 6 weeks ago if it was a specific type called nitrosourea.I finished my immunotherapy more than 42 days ago.I had my last brain and spinal cord radiation treatment over 3 months ago.I can care for myself but may not be able to do active work or play.You need to have certain levels of blood cells and chemicals in your blood.I received my last dose of a monoclonal antibody or similar treatment over 28 days ago and have recovered from any side effects.I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.You have a large tumor that can be seen on imaging tests.I have fully recovered from any side effects of my recent surgery.I am eligible regardless of my gender, race, or ethnicity.I've had cancer treatment before and have recovered from its immediate side effects.You must have visible signs of disease in your brain on an MRI scan.You have had a very strong allergic reaction (grade 3 or higher) to a specific type of medication called a monoclonal antibody in the past.I have a high-grade brain tumor diagnosed with specific imaging.I do not have any serious illnesses or infections unrelated to my cancer.My cancer is a specific type of brain tumor that has not responded to treatment, including radiation.I am not pregnant or breastfeeding and have a recent negative pregnancy test.I have available tumor samples for testing.I haven't had a live vaccine in the last 30 days.I haven't taken any growth factor medications for over a week.You have had an organ transplant.I have another type of cancer besides the one being studied.I have been treated with anti-CTLA4 or anti-CD137 before.My neurological symptoms have been stable for at least 1 week.I received my last dose of experimental or biological treatment over a week ago.I have an active hepatitis B or C infection.I can breathe normally without extra oxygen and my oxygen level is above 93%.
- Group 1: Treatment (pembrolizumab)
- 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
What potential risks are associated with utilization of Pembrolizumab?
"While the efficacy of pembrolizumab is not yet proven, limited data exists to suggest it might be safe. Thus, our team at Power gave it a score of 1 on a scale from one to three."
What are the chief goals of this investigation?
"In the span of 6 weeks, researchers will evaluate the primary outcome - a sustained objective response (PR + CR) - of this trial. Secondary measurements include radiologic responses for those not part of high-grade gliomas strata, overall survival estimates with Kaplan-Meier distributions and log rank tests/Cox regression models to explore biomarker correlations between progression free survival and overall survival."
What prior investigations have been completed with Pembrolizumab?
"Pembrolizumab was first investigated at City of Hope as far back as 2010. As of present, there are 812 completed studies and an additional 963 active trials in progress; many of which are located in Toronto."
How many participants are engaged in this experiment?
"That is accurate. Data posted on clinicaltrials.gov verifies that this research trial, which was initially published on May 22nd 2015, is actively recruiting participants. The total of 110 individuals needed to be recruited from 6 distinct medical centres."
Am I eligible to take part in this research initiative?
"This medical trial is ideal for those with Lynch syndrome aged between 1 Year and 29. Approximately 110 individuals are eligible to partake in this research project."
How many medical centers are currently conducting this experiment?
"This trial is recruiting across 6 centres, such as Hospital for Sick Children in Toronto and Cincinnati Children's Hospital Medical Center in Cincinnati. Other locations include Lucile Packard Children's Hospital Stanford University in Palo Alto and 3 further medical sites."
Are there any current opportunities to participate in this trial?
"Indeed, the trial is currently open for enrollment. According to clinicaltrials.gov, it was initially uploaded on May 22nd 2015 and its most recent update happened on November 24th 2022. This research effort requires 110 participants from 6 different medical facilities."
Does this research trial extend to those below the age of 25?
"The requirements to participate in this study necessitate that the patient fall between 1 year and 29 years of age. Clinicialtrials.gov features 964 trials for people under 18, as well as 5368 for those over 65."
For which medical conditions has Pembrolizumab been deemed an effective treatment?
"Pembrolizumab is commonly prescribed to treat cancerous neoplasms, and can also be used for cases of malignant melanoma that are inoperable, those with advanced microsatellite instability high, or post-chemotherapy disease progression."
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