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Adoptive Cellular Therapy for Brain Cancer (ACTION Trial)
ACTION Trial Summary
This trial is testing whether a vaccine made from a person's own tumor can help the body's immune system better recognize and fight the cancer.
ACTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowACTION Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ACTION Trial Design
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Who is running the clinical trial?
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- I am mostly able to care for myself and carry out daily activities.My kidney function, measured by creatinine, is within the normal range.I or my guardian agree to a stem cell collection after signing up.My neurological condition has been stable for at least a week.I have an autoimmune disease, immunosuppression, or HIV.I do not have major heart, kidney, liver, lung, or other organ problems.I am scheduled for surgery to remove a high-grade brain tumor.My liver function tests are within the required limits.My brain tumor is a high-grade (III or IV) glioma.I am willing and able to receive treatment and follow-up at the Sunshine Project site.
- Group 1: Group B
- Group 2: Group A
- 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
Has the Td vaccine received clearance from the FDA?
"Judging by the existing information, our team at Power gave the Td vaccine a safety rating of 1 due to its phase 1 status. This implies that there is minimal evidence suggesting its efficacy and protection."
What is the scope of participants enrolled in this research?
"A total of 10 volunteers, who meet the predefined requirements for participation, are required to be enrolled in this trial. Those wishing to participate may do so at UF Health Shands Children's Hospital located in Gainesville Florida and/or Children's National Hospital based out of Washington D.C."
Is enrollment still ongoing for this experiment?
"According to the information archived on clinicaltrials.gov, this trial is actively recruiting participants at present time. It was originally posted on May 16th 2018 and has been updated most recently in August of 2022."
Does this research encompass elderly individuals aged 75 and older?
"This trial has established a participant age range of 3 to 21 years old, in accordance with pre-defined inclusion criteria."
Are the criteria I meet sufficient to allow me to join this experiment?
"This clinical trial seeks 10 children with glioma between 3 and 21 years old, who meet the following prerequisites: Histological confirmation of WHO Grade III or IV malignant glioma, Scheduled for definitive surgical resection of suspected HGG (biopsy only subjects are not eligible), Karnofsky Performance Status (KPS) ≥ 60%/Lansky performance Score (LPS) ≥60 depending on age, Absolute neutrophil count (ANC) ≥ 1000/µl; platelets ≥100,000 µl; hemoglobin > 8 g/dL; serum creatinine ≤ upper limit of institutional normal"
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