(BRAVO) Newly-Diagnosed Brain Stem Gliomas Treated with Adoptive Cellular Therapy During Recovery from Focal Radiotherapy Alone or Focal Radiotherapy and Dose-intensified Temozolomide

Purpose

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

  • 3 - 21 years old
  • Disease: Pediatric brain tumor
  • Disease type: Diffuse Intrinsic Pontine Glioma (DIPG)
For additional information about eligibility criteria, please contact the study coordinator Marcia Hodik: 

Procedures

  • Drug: Dendritic cell vaccine and tumor-specific immune cells
  • Drug type: Immunotherapy using 

Full details regarding study procedures can be explained by the study coordinator Marcia Hodik: 

Age

N/A

Gender

Male
Female

Can be done from home

No

Keywords

Brain Tumors, Pediatric Brain Tumors, Brain Tumor, Brain tumor - children, Immunotherapy

Principal Investigator

Sridharan Gururangan, FRCP

Contact Information

marcia.hodik@neurosurgery.ufl.edu

352.273.6971


Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at CTSI-Studies-L@lists.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

For Research Teams