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NCT03396575 · ClinicalTrials.gov registry record · Phase 1
Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)
A Phase 1 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03396575 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 11 participants.
The verdict
NCT03396575, a Phase 1 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL TTRNA-DC vaccines with GM-CSF
- BIOLOGICAL TTRNA-xALT
- DRUG Td vaccine
- DRUG Cyclophosphamide + Fludarabine Lymphodepletive Conditioning
- DRUG Dose-Intensified TMZ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-07-17 |
| Est. Completion | 2025-03-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03396575
The ClinicalTrials.gov registry entry for NCT03396575 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which TTRNA-DC vaccines with GM-CSF is the first listed.
NCT03396575 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03396575 about?
NCT03396575 is a clinical study titled "Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)". 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 t...
What is the current status of trial NCT03396575?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-07-17. Estimated completion is 2025-03-20.
What interventions are being tested in trial NCT03396575?
The interventions under investigation include: TTRNA-DC vaccines with GM-CSF (BIOLOGICAL), TTRNA-xALT (BIOLOGICAL), Td vaccine (DRUG), Cyclophosphamide + Fludarabine Lymphodepletive Conditioning (DRUG), Dose-Intensified TMZ (DRUG).
Who is sponsoring clinical trial NCT03396575?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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