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Carfilzomib + Cyclophosphamide + Etoposide for Pediatric Cancer (POE14-01 Trial)
POE14-01 Trial Summary
This trial is testing a new combination of drugs to treat children with relapsed/refractory leukemia or solid tumors. The drugs are carfilzomib, cyclophosphamide, and etoposide. The trial will test if this combination is safe and what the maximum tolerated dose is.
POE14-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPOE14-01 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 126 Patients • NCT03029234POE14-01 Trial Design
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Who is running the clinical trial?
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- You have a rare condition called Fanconi Anemia or another condition that affects your bone marrow's ability to function properly.You are of reproductive age and able to have children.You have Down syndrome.You are allergic to Captisol®, a substance used to dissolve carfilzomib.Patients must have one of the following conditions:You have received previous treatment for your condition.You have a serious health condition alongside the one being studied.You have received treatment with carfilzomib in the past.You have a type of cancer that has come back or is not responding to standard treatments. You do not have tumors in your brain or any other parts of your central nervous system. Having lymphoma is allowed. It is not necessary for you to have measurable disease.
- Group 1: Carfilzomib
- 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
Are there any US-based healthcare centers conducting research on this topic?
"Currently, this clinical trial is enrolling out of 7 different sites located in San Antonio, Phoenix and Hershey as well as four other cities. To reduce the amount of time spent travelling to a medical centre for participation, it may be best to choose the one closest to you."
Is enrollment currently open for this clinical experiment?
"Per clinicaltrials.gov, this investigation is still recruiting patients and has been since February 16th 2016. The trial's data was most recently updated on April 12th 2022."
Is it possible for me to participate in this clinical experiment?
"For this clinical trial, 50 patients between 6 months and 29 years of age with leukemia or other non-CNS solid tumors are being recruited. Candidates must have relapsed/refractory diseases that haven't responded to standard treatments, an estimated life expectancy of at least 3 months, a Lansky or Karnofsky score higher than 50%, and be recovered from any prior chemotherapy. Additionally, it is necessary that 14 days have elapsed since the administration of myelosuppressive therapy or biologic agents such as monoclonal antibodies and radiation therapies; 90 days if substantial bone marrow radiation has been administered."
Is participation for individuals aged 25 or older permissible in this experiment?
"Based on the outlined requirements, this trial has a lower age limit of 6 months and an upper boundary at 29 years old."
Can you elaborate on the additional investigations involving Carfilzomib?
"Presently, 1065 Carfilzomib studies are operational; with 217 in their final stages. Philadelphia, Pennsylvania has the highest concentration of trials for this medication but it is being researched at 38682 different facilities worldwide."
Could you explain the risks associated with Carfilzomib use?
"Based on the limited amount of data available, Carfilzomib has been assigned a score of 1 for safety. This is because it is currently in Phase 1 trials and there are few studies to corroborate its efficacy or security protocols."
What is the scale of participation for this clinical experiment?
"This clinical trial necessitates the recruitment of 50 appropriate participants. For this endeavor, Amgen is partnering with University of Texas Health Science Center at San Antonio and Phoenix Children's Hospital to carry out their research."
To what conditions does Carfilzomib offer therapeutic relief?
"Carfilzomib is usually used for the treatment of leukemia, but it can also be applied to address prostate cancer, lung cancers and small cell ell lung cancer (sclc)."
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