In Delaware’s first gene therapy trial, Christiana Care doctors are using genetically engineered cells from a patient’s own blood to trigger the destruction of cancer cells in his leg and foot.
“I’m not a hero,” says the patient, Howard Anderson, “just a lucky guy who is hoping this trial will not only extend my life but benefit other people down the road.”
This historic clinical trial under way for advanced melanoma marks the Helen F. Graham Cancer Center’s first foray into cancer gene therapy.
Christiana Care is the only East Coast center participating in this early-phase study and one of only 11 participating sites nationwide.
For Anderson, 72, of Middletown, Del., this new melanoma vaccine could be what finally stops the cancer that has spread from his left calf down to his foot. Anderson is the first patient in the region to enter the trial and undergo collection of his white blood cells to make his personalized vaccine.
Another first at Christiana Care
“We are crossing a number of thresholds with this clinical trial,” said Michael Guarino, M.D., principal investigator at the Helen F. Graham Cancer Center.
The trial aims to test drug dosage and efficacy and is the first of its kind ever offered to patients at the Helen F. Graham Cancer Center. A specially designed pill controls the vaccine’s anti-tumor action.
Key players are the dendritic cells, white blood cells that help regulate the immune system. A process called aphaeresis extracts dendritic cells from the patient’s white blood cells, similar to collecting peripheral blood stem cells from a donor to treat leukemia or lymphoma.
The study team at the Helen F. Graham Cancer Center ships the cells to the University of Nebraska. Clinical researchers there program them to recognize the patient’s tumor cells and release a protein called IL-12, fitted with an on/off switch to regulate the body’s defense mechanisms. The University ships the “programmed” dendritic cells back to the Cancer Center, where doctors inject them into the patient’s tumor just below the skin surface.
Following the vaccine injection, each patient on the trial takes a pill for 14 days. A molecule in the pill signals the dendritic cells to release the protein to the tumor and recruit other immune system “killer cells” to attack.
“What’s different about this vaccine is that it doesn’t go to work until the activator switch – the signaling molecule – is turned on by taking the pill,” Dr. Guarino said. “This potentially reduces the patient’s drug level for a safer treatment.”
Once “educated” to attack, the killer cells take that knowledge and migrate to other tumor sites in the body to destroy cancer cells.
At Christiana Care, the trial is open for patients with stage 3 or 4 melanoma who have not responded well to chemotherapy or other treatments and who have tumors accessible for biopsy.
“Patients receive four injections of the vaccine with an escalating dose of the activator pill in four 28-day cycles,” explained Research Nurse Supervisor Kathy Combs, RN, OCN, CCRP.
Newest cancer treatments right here in Delaware
“Our emerging leadership in cancer genetics and clinical research is making it increasingly preferable for patients in Delaware and surrounding communities to entrust their cancer care to our team at the Helen F. Graham Cancer Center,” said Nicholas J. Petrelli, M.D., Bank of America endowed medical director. “There is simply no need to travel long distances to find the newest, most promising cancer treatments. They are available right here in our state.”
Anderson agrees. “I was awful nervous, but it was worth the trip,” he said. “Everyone at the Cancer Center was just wonderful—Dr. Guarino, the nurses, the people at the Infusion Center all raised my comfort level.
“I’m very thankful with the help of family and friends to get to therapy,” he added, “If I had to travel farther, it would be very difficult.”