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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: Clinical Trial Phase 1 study, sponsored by University of Florida.
NCT03396575 is a Phase 1 study that was terminated before completion, run by University of Florida. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of subjects with immunotherapy-related dose-limiting toxicities including 1) Grade III or greater non-neurologic toxicity; 2) Grade III neurologic toxicity that does not improve to Grade II or better within 5 days; or 3) Grade IV neurologic toxicity.
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 |
Why NCT03396575 stopped before completion
NCT03396575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which TTRNA-DC vaccines with GM-CSF is the first listed.
NCT03396575 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03396575's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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