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Autologous dendritic cells will be pulsed with human recombinant oncofetal antigen (OFP/iLRP). The vaccine will be injected intradermally.

Dendritic Cell Vaccination

Paul O. Schwarzenberger, M.D.

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 his or her own, that 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 cannula 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.

Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer

Phase I/II Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer

University of South Alabama

Quantum Immunologics, Inc.

Charles Broes, CEO

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer	NCT00879489	Breast Cancer	Dendritic Cell ...	18 Years - 85 Years	Quantum Immunologics, Inc.
Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer	NCT00879489	Breast Cancer	Dendritic Cell ...	18 Years - 85 Years	Quantum Immunologics, Inc.

Spots Global Cancer Trial Database for stage iv histologically proven breast cancer