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NCT00082641 · ClinicalTrials.gov registry record · Phase 1

Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer

A Phase 1 study, sponsored by University of Nebraska.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00082641 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 24 participants.

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The verdict

NCT00082641, a Phase 1 study, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or after chemotherapy and radiation therapy may cause a stronger immune response. PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53.

Interventions

  • BIOLOGICAL autologous dendritic cell-adenovirus p53 vaccine

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2004-01-01
Est. Completion 2018-01-01
Phase Phase 1

Sponsor

University of Nebraska

407 total trials

What the Registry Record Tells You About NCT00082641

The ClinicalTrials.gov registry entry for NCT00082641 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which autologous dendritic cell-adenovirus p53 vaccine is the first listed.

NCT00082641 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00082641 about?

NCT00082641 is a clinical study titled "Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer". RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to da...

What is the current status of trial NCT00082641?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2004-01-01. Estimated completion is 2018-01-01.

What interventions are being tested in trial NCT00082641?

The interventions under investigation include: autologous dendritic cell-adenovirus p53 vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00082641?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

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

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.