Woman Diagnosed with Advanced Melanoma in 2005 Remains Disease-Free Thanks to Clinical Trial Conducted at St. Luke’s
Cancer Expert Lee B. Riley, MD, PhD Served as Co-Investigator and Co-Author in the Phase III Melanoma Vaccine Trial for Patients with Advanced Disease
Suzanne Lapierre-Roman of Allentown was diagnosed with metastatic melanoma at age 29 in July of 2005. The news came as a complete surprise. While pregnant with her fourth child, Suzanne was experiencing pain thought to be caused by her gallbladder, and soon after delivery, had it removed. Test results that came back showed she had cancer – advanced melanoma. “It was a shock,” she says. “At the time, I didn’t even know what melanoma was.”
Suzanne was first seen at a number of university hospitals in Philadelphia and then a local hospital. “I wasn’t given much hope,” she says. “I was told to go on chemotherapy. Then, I heard about Dr. Lee Riley at St. Luke’s. He tested me to see if I would qualify for a melanoma clinical trial. I went on in October 2005.”
The treatment, formulated by National Cancer Institute (NCI) investigators, involves the use of a potent designer peptide vaccine gp100:209-217 (210M) which mimics the antigen that sits on the surface of a patient’s own tumor cells. On its own, the peptide shows little activity. However, in this trial, the vaccine was given in combination with the FDA-approved inpatient therapy for melanoma, High-Dose IL-2, made from a natural protein produced by the body.Dr. Riley, Medical Director of St. Luke’s Cancer Center, served as a co-author and a clinical investigator for the randomized study. St. Luke’s Cancer Center in Bethlehem was the only site in Pennsylvania to participate in the trial and was a major contributor of study participants, including Suzanne. Dr. Riley joined on as an investigator in the study in 2002. The promising results of the trial were presented at the June 2009 meeting of the American Society of Clinical Oncology in Orlando, Florida.
It’s been nearly four years since Suzanne went on the trial and today she is totally disease-free. “Dr. Riley was the only one who gave me hope,” she says. “He told me, ‘When this treatment works, it’s a home run.’ Well, I got my home run. Today, I don’t have any signs of the disease. Dr. Riley is just awesome; I owe him my life.”
“Suzanne’s great results are typical for someone who responds to IL-2, and there is a very good chance she will not have a recurrence. This study suggests that, in the future, more than twice as many people should respond the way Suzanne has,” says Dr. Riley.
Dr. Riley stresses the significance of this study. “The trial has demonstrated for the first time that, a vaccine can improve the outcome of patients with the most advanced stage of melanoma (stage IV). This is a major advance for cancer vaccine research and should stimulate additional cancer vaccine studies.”
More about the study
One hundred and eighty-five patients were enrolled in the study in 21 states from 2000 to 2007. The majority of patients in this study were between the ages of 31 and 60 and had advanced disease. All of the patients were heavily pretreated with surgery and, in some cases, patients had also undergone prior chemotherapy, radiation therapy, or immunotherapy including IL-2.
Study participants received two to four vaccine injections every three weeks. The study showed that those who received the vaccine with high-dose IL-2 had a significant response rate, 22.1 percent compared to 9.7 percent who just received the high-dose IL-2. The overall survival for those receiving the vaccine with IL-2 was 17.6 months compared to 12.8 months (p=0.084).
“The vaccine induces anti-tumor T-cells and the IL-2 stimulates the T-cells to grow and divide,” says Dr. Riley. “T-cells belong to a group of white blood cells known as lymphocytes and play a central role in cell-mediated immunity.”
Now that the study is over, the trial’s investigators are evaluating ways to move it forward so that others with advanced melanoma may also benefit.
Source:http://wellspringhealthandstyle.com/2009/08/20/woman-diagnosed-with-advanced-melanoma-in-2005-remains-disease-free/
The use of a potent designer peptide vaccine gp100:209-217 (210M) which mimics the antigen that sits on the surface of a patient’s own tumor cells. It is used as the Antigen, for the Antigen Presenting Cell (APC)
Take Care,
Jimmy B
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