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NCT01811992 · ClinicalTrials.gov registry record · Phase 1
Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma
A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01811992: Completed Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT01811992 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01811992, a Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Despite the marginal improvements in survival of patients suffering from malignant glioma treated with gene therapy vectors, the clinical trials conducted so far using viral vectors, in particular adenoviral vectors, have proven that the use of adenoviral vectors is a safe therapeutic approach, even in large, multicenter, phase 3 clinical trials. Treatment of malignant glioma using gene transfer modalities typically consists of surgical debulking of the tumor mass followed by the administration of the viral vectors into the brain tissue surrounding the tumor cavity. This study will combine direct tumor cell killing (TK) and immune-mediated stimulatory (Flt3L) gene transfer approaches delivered by first generation adenoviral vectors.
Primary Outcome
Vectors AdhCMV- TK and Ad-hCMV-Flt3L were administered at time of surgery and the MTD determined by dose-limiting toxicities. Toxicities assessed and graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Interventions
- BIOLOGICAL Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-04 |
| Est. Completion | 2021-01 |
| Phase | Phase 1 |
What the finished NCT01811992 record still lists
NCT01811992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L is the first listed.
NCT01811992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01811992 about?
NCT01811992 is a clinical study titled "Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma". Despite the marginal improvements in survival of patients suffering from malignant glioma treated with gene therapy vectors, the clinical trials conducted so far using viral vectors, in particular adenoviral vectors, have proven that the use of adenoviral vectors is a safe therapeutic approach, even...
What is the current status of trial NCT01811992?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2014-04. Estimated completion is 2021-01.
What interventions are being tested in trial NCT01811992?
The interventions under investigation include: Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L (BIOLOGICAL).
Who is sponsoring clinical trial NCT01811992?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01811992's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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