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NCT00403221 · ClinicalTrials.gov registry record · Phase 1

Phase I - Pre-Radical Prostatectomy RTVP-1 Gene Therapy for Prostate Cancer

A Phase 1 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT00403221 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 19 participants.

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The verdict

NCT00403221, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

The purpose of this study is to conduct a Phase I clinical trial involving in situ RTVP-1 gene therapy for prostate cancer. We will conduct necessary safety evaluations on a new adenovirus that contains the human genes for RTVP-1. This virus will then be evaluated for safety in men with prostate cancer prior to radical prostatectomy. Based on the preclinical data, we hope that this treatment will induce not only a local cytotoxic and antiangiogenic effect but also, a systemic antitumor immune response capable of eradicating micrometastatic disease (the reason for recurrence in many of these patients).

Interventions

  • GENETIC RTVP-1 Gene

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2006-08
Est. Completion 2011-04
Phase Phase 1

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT00403221

The ClinicalTrials.gov registry entry for NCT00403221 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 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 RTVP-1 Gene is the first listed.

NCT00403221 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00403221 about?

NCT00403221 is a clinical study titled "Phase I - Pre-Radical Prostatectomy RTVP-1 Gene Therapy for Prostate Cancer". The purpose of this study is to conduct a Phase I clinical trial involving in situ RTVP-1 gene therapy for prostate cancer. We will conduct necessary safety evaluations on a new adenovirus that contains the human genes for RTVP-1. This virus will then be evaluated for safety in men with prostate can...

What is the current status of trial NCT00403221?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2006-08. Estimated completion is 2011-04.

What interventions are being tested in trial NCT00403221?

The interventions under investigation include: RTVP-1 Gene (GENETIC).

Who is sponsoring clinical trial NCT00403221?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.