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WVU Cancer Institute enrolls first patients in breast cancer vaccine trial

When Linda Carleo’s oncologist told her he couldn’t help her with her second case of breast cancer, she came to the WVU Cancer Institute, where she agreed to become part of a clinical trial for a new vaccine.

“I’m a survivor and I will fight this,” she said. “So I decided I would come here. … I’m very happy with this program. I don’t have to take that terrible chemo. It’s horrible stuff, I mean, the worst.”

Carleo lives in Mount Clare, Harrison County and turned 70 on the day she talked to The Dominion Post. So far, she’s had no side effects from the vaccine and feels good, she said. “I really like it, a lot.”

The Cancer Institute is one of 11 cancer centers across the country participating in this research project of the Pittsburgh-based NSABP Foundation – short for National Surgical Adjuvant Breast and Bowel Project.

This is one of NASBP’s 11 current breast cancer treatment clinical trials. It’s investigating the use of AE37 peptide vaccine in conjunction with pembrolizumab immunotherapy infusions. Pembrolizumab, sometimes known by brand name Keytruda, is a humanized antibody.

Dr. Sobha Kurian, a WVU Medicine oncologist and primary investigator on this project, explained, “We are using the vaccine to wake up the body’s immunity and attack the cancer so it can get rid of the cancer by her own immunity being reactivated.”

Usually, she said, vaccines are given to prevent development of a disease. This one is given after the cancer forms to help stimulate the disease-fighting process.

The vaccine-immunotherapy combination is being tested on patients with triple-negative breast cancer, said Kurian said. Triple-negative means the cancer is not estrogen receptor-positive, progesterone receptor-positive or HER2-postivie (human epidermal growth factor receptor 2), where the hormones fuel the cancer cell growth.

Usually, only chemotherapy works to treat triple-negative, she said, so this research is hoping to provide an alternative.

Carleo said she first developed breast cancer eight years ago – a mass on her breast. It was surgically removed and she was treated with radiation and chemo.

It came back last May. This time, the cancer developed outside of the breast, in the skin and lymph nodes, Kurian said, where it’s hard to remove surgically. Because of the prior radiation treatment, she wasn’t eligible to receive it again.

Carleo has received five treatments so far under the trial, Kurian said. She receives the Keytruda infusion intravenously, plus vaccine injections in each leg.

Carleo will have a CT scan in January to evaluate the healing process. The vaccine portion is complete but she has one more immunotherapy session planned. Carleo will be monitored for another 90 days, and they will then decide if they should continue immunotherapy or switch to a chemo pill.

They will be happy if the treatment both stops the cancer cell growth and eradicates them, Kurian said. But eradication is harder and usually takes time. If the therapy stops the growth and starts the cancer regressing to allow the body to fight the cancer with its own immune cells, that’s what they’re hoping for.

“We are so happy she was willing to participate and be part of this trial,” Kurian said.

Across the board, the NSABP trial has been successful so far, Kurian said, so the foundation is looking to expand it. The Cancer Institute had enrolled two patients for the initial 29-patient national trial, and now they hope to add four to five more at WVU.

Carleo said she sought her family’s advice when the cancer came back in May. “They said, ‘Mom, you should do everything that you can do. It’s your life and you’re fighting for your life.’ ”

Carleo agreed. “I’m a survivor. I feel I can fight this. And I feel I can do whatever I have to do.”

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