← Back to Search

Cancer Vaccine

Immunotherapy + Radiotherapy for Brain Stem Glioma (BRAVO Trial)

Phase 1
Waitlist Available
Led By Sridharan Gururangan, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Initial Screening: Radiologically confirmed DIPG or other diffuse intrinsic brain stem glioma (Grade III or IV)
Biopsy confirmation of any grade of glioma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

BRAVO Trial Summary

This trial is testing whether adding immunotherapy to radiotherapy and temozolomide helps children with DIPG.

Who is the study for?
This trial is for children with a specific brain tumor called DIPG or other diffuse intrinsic brain stem gliomas. They must be stable after surgery, have certain blood and organ function levels, and agree to use birth control if applicable. Those with severe allergies to the drugs used in this study, significant organ dysfunction, unstable medical conditions, or who cannot follow the study procedures are not eligible.Check my eligibility
What is being tested?
The trial tests two approaches for treating brain tumors: Group A gets radiotherapy plus chemotherapy (TMZ) and immunotherapy; Group B gets only radiotherapy followed by immunotherapy. The focus is on how well patients respond to immune system-boosting treatments during and after these therapies.See study design
What are the potential side effects?
Possible side effects include low blood cell counts leading to increased infection risk, fatigue from anemia or treatment-related stress on the body's systems, allergic reactions to medications used in therapy, nausea from chemotherapy drugs like TMZ, and potential complications from biopsies.

BRAVO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My brain tumor is a high-grade stem glioma confirmed by imaging.
Select...
My brain tumor has been confirmed by a biopsy.
Select...
My kidney function, measured by creatinine, is within normal range.
Select...
My liver function tests are within the required limits.

BRAVO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Determine the maximally achievable dose (MAD) or maximum tolerated dose (MTD) of xALT plus DC and HSC in Group A and Group B subjects
Feasibility and safety of adoptive cellular therapy in pediatric patients with DIPG with or without dose-intensified TMZ during cycles of DC vaccination
Secondary outcome measures
Analysis of overall survival (OS)
Analysis of progression-free survival (PFS)
Post-immunotherapy functional anti-tumor immune responses

BRAVO Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment5 Interventions
TTRNA-DC vaccines with GM-CSF and TTRNA-xALT plus Td vaccine with Autologous Hematopoietic Stem cells (HSCs) with Cyclophosphamide + Fludarabine Lymphodepletive Conditioning
Group II: Group AExperimental Treatment5 Interventions
TTRNA-DC vaccines with GM-CSF and TTRNA-xALT plus Td vaccine with Autologous Hematopoietic Stem cells (HSCs) during cycles of Dose-intensified TMZ

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,684 Total Patients Enrolled
Lyla Nsouli FoundationUNKNOWN
Accelerate Brain Cancer CureOTHER
3 Previous Clinical Trials
330 Total Patients Enrolled

Media Library

TTRNA-DC vaccines with GM-CSF (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03396575 — Phase 1
Brain Stem Glioma Research Study Groups: Group A, Group B
Brain Stem Glioma Clinical Trial 2023: TTRNA-DC vaccines with GM-CSF Highlights & Side Effects. Trial Name: NCT03396575 — Phase 1
TTRNA-DC vaccines with GM-CSF (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03396575 — Phase 1

Frequently Asked Questions

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

Who is qualified to partake in the trial?

"21 individuals with brain stem gliomas aged 3 to 30 are welcomed as part of this trial. Critically, potential participants must consent to a biopsy for diagnostic purposes and RNA extraction, maintain platelets above 100K/µl (unsupported), and have an ANC ≥ 1000/µl (unsupported). Furthermore, KPS or LPS must be > 50% within two weeks prior to enrollment."

Answered by AI

Is elderly eligibility being considered for this medical experiment?

"This trial is inviting applicants between the ages of 3 and 30 to join."

Answered by AI

What endemic or epidemic diseases is the Td vaccine commonly employed against?

"Td vaccine is the standard treatment for multiple sclerosis and has shown to be efficacious at treating additional medical conditions like mixed-cell type lymphoma, myelocytic leukemia, acute forms of leukemia, as well as retinoblastoma."

Answered by AI

How many individuals are currently enrolled in this trial?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this research project, which was originally published on May 17th 2018, is presently searching for willing participants. 21 individuals must be enrolled from one medical facility."

Answered by AI

Are there current opportunities for patients to participate in this clinical investigation?

"According to clinicaltrials.gov, this drug trial is actively seeking patients. The initial post was on 17th May 2018 with the most recent update being 22nd August 2022."

Answered by AI

Are there any other existing studies that focus on the efficacy of Td vaccine?

"Presently, there is a massive body of clinical trials researching the Td vaccine. Of these 889 active studies, 161 have progressed to Phase 3. While several are based in Philadelphia, Pennsylvania; across 28443 locations worldwide scientists and clinicians study this potential treatment."

Answered by AI

Has the Td vaccine been authorized by the FDA?

"This vaccine has yet to be fully evaluated, so it was given a score of 1 in terms of safety. This is because this particular trial is only at the initial stages, where there exist limited data on its efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)
2018. "Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03396575.
~2 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top