By Cindy Krischer Goodman | [email protected] | South Florida Sun Sentinel

A runner, Judith Hetlage repeatedly felt pain in her left lower leg while on her daily path around Davie.

Several trips to the orthopedist, however, left her frustrated and without an explanation.

Eventually, though, Hetlage's primary doctor ordered a scan of her calf that showed a tumor, and a biopsy led to the diagnosis of a rare cancer of the soft tissue called synovial sarcoma. Her initial treatment at Dana-Farber Cancer Institute in Boston -- involving chemotherapy, radiation, and surgery -- seemed successful, and Hetlage followed up regularly with quarterly scans.

Ten years later, though, what began w as synovial sarcoma in her calf ultimately resulted in cancer cells spreading to her lungs. "I felt like that was the death sentence," Hetlage said. "There were 13 tumors in my lungs in a matter of three months."

Hetlage, 65, has some hope in what could be a medical breakthrough.

She is enrolled in a pioneering clinical trial that has implications far beyond her rare form of cancer. Through Memorial Cancer Institute and its partnership with Moffett Cancer Center, she is participating in a trial for T-cell Receptor Therapy (TCR-T). The treatment is an immunotherapy that harvests a patient's T-cells, a type of white blood cell that helps the body's immune system fight disease. After removal, the T-cells are genetically modified to recognize a specific protein within cancer cells and infused back into the patient's immune system to search and destroy the diseased cells.

It is the first engineered cell therapy for solid tumor cancer approved in the United States. If effective in trial participants, it could extend the reach of TCR-T cells for use beyond just blood cancers to solid tumor cancer in the head and neck, lungs, and skin. Cancer patients whose disease has been resistant to traditional chemotherapy drugs or metastasized within their bodies could benefit.

For Hetlage's type of rare cancer, the standard treatment after the disease spreads is chemotherapy. She had begun chemotherapy while waiting to be accepted into the trial.

According to the National Cancer Institute, it has been more than a decade since the FDA approved a new therapy for synovial sarcoma.

"There is an exceedingly high need for new treatment options for patients," said Dr. Sandra D'Angelo of Memorial Sloan Kettering Cancer Center, who led a small, initial trial of TCR-T for 44 people with synovial sarcoma. The therapy shrank tumors in 19 participants and kept tumors from growing for an average of six months. For two participants, tumors went away and did not return during the three-year study period, according to D'Angelo's report for the National Cancer Institute.

Initially, Hetlage's type of cancer hadn't been included in the current national trial of TCR-T for solid tumors. However, the FDA cleared Hetlage to participate. She began treatment three months ago.

"We took her cells and we activated them in a way that now they will recognize her cancer," said Dr. Atif Hussein, Hetlage's oncologist and director of Memorial's Hematology & Oncology Fellowship training program.

Hussein said he infused Hetlage with "super immune cells" and then gave her a second dose about two weeks later to empower her immune system, which had been depleted and emptied of bone marrow prior to the treatment. The process, called lymph depletion therapy, allows the supercells to find a home in the immune system.

While a similar approach has been successfully used to treat blood cancers, it had never before been used on solid tumors. Now, at least 30 clinical trials of engineered TCR-T cells are underway for a variety of solid tumor types including melanoma, lung and colon cancer.

Patients have to qualify for Memorial's TCR-T trial by having a specific immune type. Hussein said dozens of his patients with other types of cancer did not have the right immune type to qualify, but Hetlage did. "Hopefully, we'll have more who will qualify for this study," he said.

So far, it's too soon to know whether the treatment will work for Hetlage.

At a cancer survivor's event at Memorial Cancer Institute, Hetlage, a mother of three daughters and former occupational therapist, stood behind the podium, telling other cancer patients: "I'm not a survivor yet; it's not the end. I believe that survivorship is the day you're diagnosed. I believe that it's all the ups and downs. I stand in the storm. It's about being here and continuing to fight. You can't give in."

Hussein is optimistic about Hetlage's outcome: "I have been doing oncology for 26 years and I have rarely seen somebody who is so positive, so strong. She is empowering herself, fighting so hard, and if anybody is going to respond, it is somebody like Judith."

Hetlage says she meditates, eats a healthy diet and walks six to seven miles a day. "I believe your head has got to be in the game," she said. "You've got to do the best you can do for yourself while they're doing the medical end."

"Everyone else I had ever known that had this (type of cancer) isn't still on this earth," she said. "This is something I'm going to have to watch and fight the rest of my life."

Hussein said if T-cell receptor therapy can treat solid tumors, it will represent hope in the fight against cancer. He predicts that new cell therapies will be tested in patients in the coming years and represent the next wave of cancer treatment.