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NCT01326104 · ClinicalTrials.gov registry record · Phase 2
Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01326104: Completed Phase 2 study, sponsored by University of Florida.
NCT01326104 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01326104, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Immunotherapy is a specific approach to treating cancer that has shown promise in adult patients for the treatment of melanoma, malignant brain tumors, and other cancers. The study investigators will use the experience they have gained from these studies to try to improve the outcome for children affected by a recurrent brain tumor. Approximately 35 patients with first recurrence of medulloblastoma (reMB)/supratentorial primitive neuroectodermal tumors (PNETs) will be treated with tumor-specific immune cells and dendritic cell vaccines to see what impact they have on the tumor.
Primary Outcome
PFS-12 is the number of participants (%) with PFS at 12 months. PFS is defined as time interval from date of first DC vaccine to date of progression (death is also treated as progression) or censoring, whichever happens first. The PFS-12 of Historical Benchmark is 33%. The granular PFS of Historical Bechmark is 4,16, 5, 12, 14, 7, 5, 5, 12, 9, 24 and 13 months (Gururangan et al,. Neuro Oncol. 2008, Table 3)
Interventions
- BIOLOGICAL TTRNA-xALT
- BIOLOGICAL TTRNA-DCs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-09-07 |
| Est. Completion | 2025-03-28 |
| Phase | Phase 2 |
What the finished NCT01326104 record still lists
NCT01326104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which TTRNA-xALT is the first listed.
NCT01326104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01326104 about?
NCT01326104 is a clinical study titled "Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor". Immunotherapy is a specific approach to treating cancer that has shown promise in adult patients for the treatment of melanoma, malignant brain tumors, and other cancers. The study investigators will use the experience they have gained from these studies to try to improve the outcome for children af...
What is the current status of trial NCT01326104?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-09-07. Estimated completion is 2025-03-28.
What interventions are being tested in trial NCT01326104?
The interventions under investigation include: TTRNA-xALT (BIOLOGICAL), TTRNA-DCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT01326104?
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 NCT01326104's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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