Phase 1 Clinical trial for a vaccine...

CLEVELAND, Ohio -- Susan G. Komen for the Cure is supporting the breast cancer vaccine research of a University Hospitals oncologist with nearly $1 million in grant money.

Dr. Joseph Baar said he hopes to begin enrolling patients in a Phase 1 clinical trial for a vaccine to prevent breast cancer recurrence by early January. The trial, which also will be available at the Cleveland Clinic, is still undergoing the regulatory approval process.

Over the summer, Baar, director of breast cancer research and the Breast Cancer Survivor Program at UH Case Medical Center, received news of the four-year, $996,900 grant to Case Western Reserve University. It is one of 94 grants that the national breast cancer organization awarded for fiscal 2013.

Baar is developing a trial to study the vaccine in women who have had metastatic, or advanced, breast cancer. He is collaborating with immunologist Walter Storkus of the University of Pittsburgh.

The vaccine strengthens the body’s T-cells, killer immune cells instrumental in helping fight off disease. These cells target the environment in which cancer cells thrive, such as blood vessels that help fuel the growth of cancerous tumors. The T-cells cut off the blood supply to those tumors, rather than to the cancer cells themselves.

Storkus identified the proper targets on cancer blood vessels and published the results of studies he conduced in mice.

After hearing Storkus give a talk a few years ago, Baar ask if he could use the science to develop a breast cancer vaccine.

Baar has been studying breast cancer vaccines for years. He is currently analyzing data from a separate study of a vaccine for patients with early-stage triple negative breast cancer.

With this new study, patients will be treated with the chemotherapy gemcitabine before they get the vaccine.

“One of the things we don’t know is when is the best time to administer the vaccine after chemotherapy,” Baar said.

Because of that, the first group of patients in the trial will get the vaccine three days after their chemo has ended. Two subsequent groups will get the vaccine seven and 10 days after chemotherapy.

Everyone will get a second vaccine seven days after the first shot.

reast Cancer Survivor Program at UH Case Medical Center, received news of the four-year, $996,900 grant to Case Western Reserve University. It is one of 94 grants that the national breast cancer organization awarded for fiscal 2013.

Baar is developing a trial to study the vaccine in women who have had metastatic, or advanced, breast cancer. He is collaborating with immunologist Walter Storkus of the University of Pittsburgh.

The vaccine strengthens the body’s T-cells, killer immune cells instrumental in helping fight off disease. These cells target the environment in which cancer cells thrive, such as blood vessels that help fuel the growth of cancerous tumors. The T-cells cut off the blood supply to those tumors, rather than to the cancer cells themselves.

Storkus identified the proper targets on cancer blood vessels and published the results of studies he conduced in mice.

After hearing Storkus give a talk a few years ago, Baar ask if he could use the science to develop a breast cancer vaccine.

Baar has been studying breast cancer vaccines for years. He is currently analyzing data from a separate study of a vaccine for patients with early-stage triple negative breast cancer.

With this new study, patients will be treated with the chemotherapy gemcitabine before they get the vaccine.

“One of the things we don’t know is when is the best time to administer the vaccine after chemotherapy,” Baar said.

Because of that, the first group of patients in the trial will get the vaccine three days after their chemo has ended. Two subsequent groups will get the vaccine seven and 10 days after chemotherapy.

Everyone will get a second vaccine seven days after the first shot.

One of the advantages of the vaccine is that it can be used with all types of metastatic breast cancer because the tumor blood vessel cells are the same. But not all women with breast cancer are good candidates.

A protein called HLA-A2 needs to be present in the breast cancer cells in order for the vaccine to work. About 40 percent of women with metastatic breast cancer have the protein, which is detected by testing the blood, Baar said.

“We’re hoping to enroll 30 patients,” Baar said. “Once we determine [the patients], we’ll collect blood from them. It’s with the cells from their blood that we would make the vaccine.”

The vaccine will be made at a specialized lab in Pittsburgh, then sent back to Cleveland where it will be administered.

http://www.cleveland.com/healthfit/index.ssf/2013/10/komen_gives_nearly_1_million_f.html