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NCT02549833 · ClinicalTrials.gov registry record · Phase 1
Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma
A Phase 1 study of Glioma and Malignant Glioma, sponsored by Jennie Taylor.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT02549833: Completed Phase 1 study of Glioma and Malignant Glioma, sponsored by Jennie Taylor.
NCT02549833 is a Phase 1 study of Glioma and Malignant Glioma that has completed, run by Jennie Taylor. The registered enrollment target is 28 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02549833, a Phase 1 study of Glioma and Malignant Glioma, has completed, sponsored by Jennie Taylor.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected glioma.
Primary Outcome
Delay of the scheduled surgery for longer than 2 weeks due to toxicity of the neoadjuvant treatment will also be considered RLT and reported for each arm will be tabulated with 95% exact (ClopperPearson) confidence intervals
Conditions Studied
Interventions
- BIOLOGICAL GBM6-AD and poly-ICLC before and after surgery
- BIOLOGICAL GBM6-AD and poly-ICLC after surgery only
Study Locations (1)
California
- University of California - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-10-17 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 1 |
What the finished NCT02549833 record still lists
NCT02549833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (87% lower).
The record links to 6 conditions, with Glioma appearing as the primary indexed condition, and to 2 interventions - of which GBM6-AD and poly-ICLC before and after surgery is the first listed.
NCT02549833 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02549833 about?
NCT02549833 is a clinical study titled "Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma". This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the regimen increases the level of type-1...
What is the current status of trial NCT02549833?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2016-10-17. Estimated completion is 2024-08-31.
What conditions does trial NCT02549833 study?
This clinical trial studies the following conditions: Glioma, Malignant Glioma, Oligodendroglioma, Glioma, Astrocytic, Oligoastrocytoma, Mixed.
What interventions are being tested in trial NCT02549833?
The interventions under investigation include: GBM6-AD and poly-ICLC before and after surgery (BIOLOGICAL), GBM6-AD and poly-ICLC after surgery only (BIOLOGICAL).
Who is sponsoring clinical trial NCT02549833?
This trial is sponsored by Jennie Taylor, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02549833 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02549833's enrollment target sits among peer trials
28 59th of 87 higher than 27 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma 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.
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