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Virus Therapy

Adoptive Cellular Therapy for Brain Cancer (ACTION Trial)

Phase 1
Waitlist Available
Led By Elias Sayour, MD, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Renal: Serum creatinine ≤ upper limit of institutional normal
Patients with histologically confirmed WHO Grade III or IV malignant glioma scheduled for definitive surgical resection of suspected HGG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

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.

Who is the study for?
This trial is for pediatric patients with high-grade gliomas who are scheduled for tumor removal surgery. They must have a certain level of physical function, normal kidney and liver tests, and agree to use birth control. It's not open to those with autoimmune diseases, HIV, severe medical conditions, or pregnant/breastfeeding individuals.Check my eligibility
What is being tested?
The study is testing whether vaccines made from a patient's own tumor can stimulate the immune system to fight brain tumors in children. It involves creating T-cell and Dendritic Cell (DC) vaccines that aim to activate the body’s natural defenses against aggressive brain cancer.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar treatments often involve risks like inflammation at injection sites, flu-like symptoms, fatigue, allergic reactions or worsening of autoimmune conditions.

ACTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine, is within the normal range.
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I am scheduled for surgery to remove a high-grade brain tumor.
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My liver function tests are within the required limits.
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My brain tumor is a high-grade (III or IV) glioma.

ACTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate safety of TTRNA-DCs and TTRNA-xALT
Secondary outcome measures
Anti-tumor immune responses
Determine feasibility of completing treatment
Overall survival (OS)
+1 more

ACTION Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment5 Interventions
Dose-intensified TMZ with TTRNA-DC vaccines with GM-CSF and TTRNA-xALT plus Td vaccine with Autologous Hematopoietic Stem cells (HSCs)
Group II: Group AExperimental Treatment4 Interventions
Dose-intensified TMZ with TTRNA-DC vaccines with GM-CSF and TTRNA-xALT plus Td vaccine without Autologous Hematopoietic Stem cells (HSCs)

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,581 Total Patients Enrolled
National Pediatric Cancer FoundationOTHER
4 Previous Clinical Trials
200 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,636 Total Patients Enrolled

Media Library

TTRNA-DC vaccines with GM-CSF (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03334305 — Phase 1
Brain Tumor Research Study Groups: Group B, Group A
Brain Tumor Clinical Trial 2023: TTRNA-DC vaccines with GM-CSF Highlights & Side Effects. Trial Name: NCT03334305 — Phase 1
TTRNA-DC vaccines with GM-CSF (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03334305 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~0 spots leftby May 2024