{"id":47387,"date":"2003-12-05T00:00:00","date_gmt":"2003-12-05T06:00:00","guid":{"rendered":"https:\/\/www.unmc.edu\/newsroom\/2003\/12\/05\/unmc-to-conduct-national-clinical-study-to-determine-besttime-during-treatment-to-introduce-breast-cancer-vaccine\/"},"modified":"2022-08-29T10:43:04","modified_gmt":"2022-08-29T15:43:04","slug":"unmc-to-conduct-national-clinical-study-to-determine-besttime-during-treatment-to-introduce-breast-cancer-vaccine","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/newsroom\/2003\/12\/05\/unmc-to-conduct-national-clinical-study-to-determine-besttime-during-treatment-to-introduce-breast-cancer-vaccine\/","title":{"rendered":"UNMC to conduct national clinical study to determine best\n\ntime during treatment to introduce breast cancer vaccine"},"content":{"rendered":"

The University of Nebraska Medical Center has received a two-year, $500,000<\/p>\n

grant to conduct a clinical breast cancer study to test the safety and<\/p>\n

effectiveness of a vaccine in combination with surgery and chemotherapy.<\/p>\n

The funding was awarded by Avon and the U.S. National Cancer Institute<\/p>\n

Progress for Patients Program.<\/p>\n

UNMC researchers expect to begin enrolling patients sometime in January.<\/p>\n

An estimated 267,000 new cases of breast cancer are expected to occur<\/p>\n

among women in the United States during 2003, resulting in an estimated<\/p>\n

39,800 deaths.<\/p>\n

The vaccine, known as INGN 225, a genetically engineered tumor vaccine,<\/p>\n

will be evaluated to treat patients with breast cancer. Two U.S. National<\/p>\n

Cancer Institute-designated cancer centers are participating in the gene<\/p>\n

therapy trial.<\/p>\n

James Talmadge, Ph.D., UNMC professor of pathology and microbiology,<\/p>\n

is principal investigator of the study. Patients will be entered into the<\/p>\n

study at UNMC by Ken Cowan, M.D., Ph.D., director of UNMC Eppley Cancer<\/p>\n

Center, and Elizabeth Reed, M.D., associate professor of internal medicine<\/p>\n

and director of the UNMC Breast Cancer Program.<\/p>\n

H. Lee Moffitt Cancer Center in Tampa, Fla., also will participate in<\/p>\n

the study by preparing the vaccine and participating in immunologic evaluations.<\/p>\n

The vaccine is manufactured by Introgen Therapeutics, Inc., of Austin,<\/p>\n

Texas.<\/p>\n

Dr. Cowan said the vaccine will provide a surveillance system, which<\/p>\n

researchers hope will eradicate any tumor cells left following treatment.<\/p>\n

The vaccine in essence would mop up any tumor cells that are left behind<\/p>\n

using the bodys immune system, Dr. Cowan said.<\/p>\n

Dr. Talmadge said the uniqueness of the study is that it will establish<\/p>\n

when during the course of a patients treatment it is best to introduce<\/p>\n

the vaccine so it will be most effective. He knows of no other studies<\/p>\n

looking at the timing of introducing cancer vaccines during treatment.<\/p>\n

He said most vaccine protocols are begun following several cycles of chemotherapy.<\/p>\n

This is a unique and very important question, said Dr. Talmadge, whos<\/p>\n

been working with breast cancer vaccines for the last five years. Im<\/p>\n

pleased with the protocol that we developed and its potential to help advance<\/p>\n

vaccine therapy for cancer. If the question of vaccine timing relative<\/p>\n

to primary chemotherapy is successfully addressed, the results could be<\/p>\n

relevant to other tumor types undergoing vaccine therapy.<\/p>\n

In other studies, we accept patients independent of the extent of prior<\/p>\n

therapy and so some respond, and some dont. We dont understand why the<\/p>\n

vaccine doesnt work with all patients and the variability in the extent<\/p>\n

of prior therapy likely contributes to the different response rates, Dr.<\/p>\n

Talmadge said.<\/p>\n

Researchers theorize that vaccinating patients earlier may result in<\/p>\n

a higher immune response to the vaccine. The vaccine is given with the<\/p>\n

hope of preventing recurrence of breast cancer.<\/p>\n

A better understanding of when to give the vaccine relative to primary<\/p>\n

therapy should improve the patients immune response to the therapy and<\/p>\n

enable us to move on to more effective protocols and vaccines, Dr. Talmadge<\/p>\n

said.<\/p>\n

In the randomized study, which will begin enrollment in January, one<\/p>\n

group of patients will receive a total of four vaccine injections during<\/p>\n

and following chemotherapy, and the other will receive a total of four<\/p>\n

vaccinations following completion of chemotherapy and radiation. Fifty<\/p>\n

patients, with stage II or stage III breast cancer, who have not yet begun<\/p>\n

surgery, chemotherapy and\/or radiation treatment, may be enrolled for the<\/p>\n

study. Stage II and III breast cancer patients are considered those with<\/p>\n

four or more lymph nodes with metastasis, and\/or a tumor the size of three<\/p>\n

centimeters.<\/p>\n

The vaccine was developed based on work by Dr. Dmitry Gabrilovich, associate<\/p>\n

professor of oncology at the Moffitt Cancer Center, and Dr. David Carbone,<\/p>\n

professor of oncology at the Vanderbilt-Ingram Cancer Center, and is exclusively<\/p>\n

licensed to Introgen Therapeutics. Previously published pre-clinical data<\/p>\n

from Dr. Gabrilovichs and Dr. Talmadges laboratories have shown that<\/p>\n

animals vaccinated with p53 vectors are protected against tumor development.<\/p>\n

INGN 225 is already being evaluated in patients with small-cell lung cancer<\/p>\n

at Moffitt Cancer Center, in a phase I study.<\/p>\n

Advexin therapy, recently designated as a Fast Track Program for head<\/p>\n

and neck cancer by the FDA, has been evaluated in numerous clinical studies<\/p>\n

including phase 3 studies for head and neck cancer, as well as phase 1<\/p>\n

and 2 studies for various types of cancer.  In these studies, Advexin<\/p>\n

uses the p53 protector gene (guardian of the genome) to directly kill<\/p>\n

cancer cells and to stop tumor growth, without harming normal cells.<\/p>\n

 <\/p>\nM oSpp<\/a><\/div><\/div>","protected":false},"excerpt":{"rendered":"

The University of Nebraska Medical Center has received a two-year, $500,000 grant to conduct a clinical breast cancer study to test the safety and effectiveness of a vaccine in combination with surgery and chemotherapy. The funding was awarded by Avon and the U.S. National Cancer Institute Progress for Patients Program. UNMC researchers expect to begin […]<\/p>\n","protected":false},"author":79,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-47387","post","type-post","status-publish","format-standard","hentry","category-uncategorized","department-press-release"],"yoast_head":"\nUNMC to conduct national clinical study to determine best time during treatment to introduce breast cancer vaccine<\/title>\n<meta name=\"description\" content=\"The University of Nebraska Medical Center 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