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NCT00406939 · ClinicalTrials.gov registry record · Phase 1
Vector Delivery of the IL-12 Gene in Men With Prostate Cancer
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00406939: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT00406939 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00406939, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This study is designed to determine the safety of IL-12 gene therapy for patients with recurrence of prostate cancer after radiation therapy and those with or without metastatic disease with a prostate gland intact. These, of course, would include recurrent prostate cancer after definitive radiation therapy. The prostate cancer will be treated with a prostatic injection of a replication-defective adenovirus vector delivering the IL-12 gene. Following virus injection, patients will be hospitalized for 23 hours for observation. Only one course of therapy will be administered. Each patient will be carefully monitored for toxic effects. Three to five patients will be tested with a low dose of virus and if there are no serious adverse side effects, the dose will be slowly escalated in subsequent groups of 3-5 patients or until unacceptable toxicity is reached. Effectiveness will be monitored by serum prostate-specific antigen (PSA), transrectal ultrasound of the prostate, prostate biopsy and comparison of survival times to historical survival times for patients with radiation recurrent prostate tumors. The primary objective of this initial study is to determine whether the treatment is associated with significant toxicity.
Interventions
- GENETIC IL-12 gene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 1998-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
What the finished NCT00406939 record still lists
NCT00406939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which IL-12 gene is the first listed.
NCT00406939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00406939 about?
NCT00406939 is a clinical study titled "Vector Delivery of the IL-12 Gene in Men With Prostate Cancer". This study is designed to determine the safety of IL-12 gene therapy for patients with recurrence of prostate cancer after radiation therapy and those with or without metastatic disease with a prostate gland intact. These, of course, would include recurrent prostate cancer after definitive radiation...
What is the current status of trial NCT00406939?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 1998-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00406939?
The interventions under investigation include: IL-12 gene (GENETIC).
Who is sponsoring clinical trial NCT00406939?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00406939's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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