Trial Summary
What is the purpose of this trial?The standard of care for children with DIPG includes focal radiotherapy (RT) but outcomes have remained dismal despite this treatment. The addition of oral Temozolomide (TMZ) concurrently with RT followed by monthly TMZ was also found to be safe but ineffective. Recent studies in adults have shown that certain types of chemotherapy induce a profound but transient lymphopenia (low blood lymphocytes) and vaccinating and/or the adoptive transfer of tumor-specific lymphocytes into the cancer patient during this lymphopenic state leads to dramatic T cell expansion and potent immunologic and clinical responses. Therefore, patients in this study will either receive concurrent TMZ during RT and immunotherapy during and after maintenance cycles of dose-intensive TMZ (Group A) or focal radiotherapy alone and immunotherapy without maintenance DI TMZ (Group B). Immune responses during cycles of DC vaccination with or without DI TMZ will be evaluated in both treatment groups.
Eligibility Criteria
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.Inclusion Criteria
My brain tumor is a high-grade stem glioma confirmed by imaging.
My brain tumor has been confirmed by a biopsy.
Patients of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control while being treated on this study
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Exclusion Criteria
Patients who are unwilling or unable to receive treatment and undergo follow-up evaluations at University of Florida
I have severe swallowing difficulties, reduced consciousness, or paralysis in all four limbs.
My biopsy did not show any cancer.
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Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
UF Health Shands Children's HospitalGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
Lyla Nsouli FoundationCollaborator
Accelerate Brain Cancer CureCollaborator