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Sirolimus + Chemotherapy for Refractory Pediatric Cancer (AflacST1502 Trial)
AflacST1502 Trial Summary
This trial will test if a combination of sirolimus, celecoxib, and low-dose etoposide alternating with cyclophosphamide can shrink tumors in children who have not responded to other treatments.
AflacST1502 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AflacST1502 Trial Design
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- Your cancer diagnosis needs to be confirmed by a tissue sample, except in certain cases.I have a brain tumor, but it is not DIPG.I am not currently taking any experimental drugs or cancer treatments.I will not use cannabis oil during the first 2 treatment cycles.I am currently taking medication that affects my body's enzyme levels.My cancer returned after initial treatment or didn't respond to it, and there's no known cure.I do not have any infections that aren't responding to treatment.My current illness cannot be cured with existing treatments.I haven't been on a stable dose of corticosteroids for the past week.You have a disease that can be seen on a medical image at the time of joining the study.My bone marrow, kidneys, liver, and lungs are working well.My cancer is a solid tumor outside the brain, including histiocytosis.My cancer has returned or is not responding to treatment, and there's no known cure.My condition is incurable with current treatments.I am 16 or younger and can do most activities.I have no lingering side effects from previous cancer treatments.I am over 16 and can do most of my daily activities by myself.My blood sugar levels are within the normal range.Your blood triglyceride level should be less than 300 mg/dL and your blood cholesterol level should also be less than 300 mg/dL.
- Group 1: Oral sirolimus, celecoxib, etoposide, and cyclophosphamide
- 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 cancerous and non-cancerous maladies does Cyclophosphamide typically address?
"While cyclophosphamide is most often used to fight lung cancer, it can also help patients with small cell lung cancer, organ transplants, and multiple sclerosis."
Is this study available to people who are not yet 40 years old?
"The age range for this clinical trial is 12 months to 30 years old."
Are we actively looking for new participants for this experiment?
"From what is available on clinicaltrials.gov, this trial is still looking for candidates. The initial posting was on 6/1/2015, with the latest update on 10/28/2021."
What is the toxicity profile of Cyclophosphamide?
"Cyclophosphamide's safety has been backed by some data in Phase 2 trials, but there is no evidence yet of the medication's efficacy. Therefore, we gave it a score of 2."
Could you list the inclusionary criteria for this experiment?
"This study is looking for 60 participants between the ages of 12 months and 30 who have malignancies. Participants must also meet the following criteria: have experienced relapse following front-line therapy, or be refractory to front-line therapy, and have tumors that carry a poor prognosis and have no known standard curative therapy. Participant's current disease state must be one for which there is no known curative therapy. Participants must also be fully recovered from acute toxic effects of all prior anti-cancer therapy. Brain tumors of all World Health Organization (WHO) grades, except diffuse intrinsic pontine glioma (DIP"
Are there similar treatments to Cyclophosphamide that have been studied before?
"City of Hope Comprehensive Cancer Center first researched cyclophosphamide in 1997 and, since then, 1834 trials have completed. 1165 more trials are currently underway, with numerous ones based in Atlanta, Georgia."
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