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NCT01204684 · ClinicalTrials.gov registry record · Phase 2
Dendritic Cell Vaccine for Patients With Brain Tumors
A Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01204684: Completed Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT01204684 is a Phase 2 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01204684, a Phase 2 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an indication of extended survival in several patients. However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together. Dendritic cells (DC) (cells which "present" or "show" cell identifiers to the immune system) isolated from the subject's own blood will be treated with tumor-cell lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed DCs will then be injected back into the patient intradermally as a vaccine. The investigators will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some treatment cohorts. It is thought that the host immune system might be taught to "recognize" the malignant brain tumor cells as "foreign" to the body by effectively presenting unique tumor antigens to the host immune cells (T-cells) in vivo.
Interventions
- BIOLOGICAL autologous tumor lysate-pulsed DC vaccination
- BIOLOGICAL Tumor lysate-pulsed DC vaccination+0.2% resiquimod
- BIOLOGICAL Tumor-lysate pulsed DC vaccination +adjuvant polyICLC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-10-08 |
| Est. Completion | 2024-08-21 |
| Phase | Phase 2 |
What the finished NCT01204684 record still lists
NCT01204684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which autologous tumor lysate-pulsed DC vaccination is the first listed.
NCT01204684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01204684 about?
NCT01204684 is a clinical study titled "Dendritic Cell Vaccine for Patients With Brain Tumors". The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an in...
What is the current status of trial NCT01204684?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-10-08. Estimated completion is 2024-08-21.
What interventions are being tested in trial NCT01204684?
The interventions under investigation include: autologous tumor lysate-pulsed DC vaccination (BIOLOGICAL), Tumor lysate-pulsed DC vaccination+0.2% resiquimod (BIOLOGICAL), Tumor-lysate pulsed DC vaccination +adjuvant polyICLC (BIOLOGICAL).
Who is sponsoring clinical trial NCT01204684?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01204684's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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