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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 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 4 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00406939
The ClinicalTrials.gov registry entry for NCT00406939 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IL-12 gene is the first listed.
NCT00406939 reports 0 study locations.
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.
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