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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

Must not have

Patients with severe dysphagia, obtundation, or tetraplegia

Absence of tumor on biopsy specimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain tumor is a high-grade stem glioma confirmed by imaging.

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My brain tumor has been confirmed by a biopsy.

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My kidney function, measured by creatinine, is within normal range.

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My liver function tests are within the required limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe swallowing difficulties, reduced consciousness, or paralysis in all four limbs.

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My biopsy did not show any cancer.

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I have an autoimmune disease, am immunosuppressed, or have HIV.

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I do not have any severe or unstable health conditions.

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I do not have major issues with my kidneys, heart, lungs, liver, or other organs.

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I need more than 4 mg/day of dexamethasone after my cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Analysis of overall survival (OS)

Analysis of progression-free survival (PFS)

Post-immunotherapy functional anti-tumor immune responses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met