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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 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 19 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01811992
The ClinicalTrials.gov registry entry for NCT01811992 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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