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Not listed Phase 1 Interventional

A Phase I Cancer Vaccine Study for Patients With Metastatic Breast Cancer

ClinicalTrials.gov ID: NCT00715832

Public ClinicalTrials.gov record NCT00715832. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 1:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I Vaccine Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study uses a molecule or particle that is found only on cancer cells and is unique to cancer cells, as it is not detected on normal tissue. The molecule is known as "oncofetal antigen" or OFA. Because OFA is unique to cancer, the investigators feel OFA could be used to educate the patients' own defenses to more effectively fight the cancer on her own, he or she is harboring. Although investigators found OFA to be present in large concentrations on all cancers, it was found to be especially abundant in breast cancers. Therefore, the investigators feel that this molecule would be a good target for stimulating patient defenses especially against breast cancer cells. To accomplish this, certain defense cells (immune cells) will be washed out from the patients' blood using a machine to which the patient is connected through two small cannulas placed into veins located in the patients' arms. Those cells will be manipulated in the laboratory with artificially engineered OFA. These "reeducated" cells will be injected into the skin of patients. There will be a series of three skin injections in 4 week intervals. It is hoped that this treatment will convert the patients' defenses to a point that effective anti cancer responses will be induced. Effectiveness of the treatment will be monitored with blood tests and assessment of the size of the cancers.

Study identification

NCT ID
NCT00715832
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Southern Cancer Center
Other
Enrollment
25 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2008
Primary completion
Jan 31, 2010
Completion
Jan 31, 2015
Last update posted
Aug 25, 2009

2008 – 2015

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Quantum Immunologics Mobile Alabama 36606 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00715832, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 25, 2009 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00715832 live on ClinicalTrials.gov.

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