SMH first site in world approved to begin enrolling patients in international clinical trial
SARASOTA, Fla. (Jan. 30, 2012) – It’s one of the most deadly forms for gynecological cancer, and until now, women with ovarian cancer had few options after treatment to keep it from recurring.
This month, Sarasota Memorial became the first site approved to begin enrolling patients in an international clinical trial testing a personalized ovarian cancer vaccine for newly diagnosed women.
Developed by the Australian biotechnology company Prima BioMed, the custom made vaccine (which uses the patients’ own white blood cells) has been developed to help patients’ immune systems prevent their cancer from recurring after traditional surgery and chemotherapy.
"This is a very personalized approach to immunotherapy,” said GYN oncologist James Fiorica, medical director of Sarasota Memorial’s women’s cancer program and principal investigator of the local trial. “The vaccine we’re studying is designed to stimulate the patient's own immune system to prevent a recurrence of the cancer. That is an exciting development in treatment, since traditional treatment methods like chemotherapy or surgery often kill cancer cells but they often return with stronger resistance.”
The vaccine, called Cvac™, is one of several personalized cancer treatments currently being studied around the world, but it is the only cancer vaccine made from dendritic cells and mucin-1 proteins found in large amounts in ovarian tumor cells. The experimental vaccine programs the body’s immune system to find and destroy recurrent cancer cells.
It is a Phase II/III trial (meaning it has passed Phase I safety studies) that will be conducted across multiple continents over the next couple of years. Randomized and placebo-controlled study, half of the patients enrolled will receive the vaccine and half a placebo injection as the control group. The purpose of this trial is to further evaluate the safety and efficacy of Cvac compared to today’s standard of care in ovarian cancer patients who are in remission after first or second-line therapy.
Sarasota Memorial was the first site in the world approved to begin enrolling patients in the study. It is being led by Dr. Fiorica, the study’s principal investigator, in conjunction with Sarasota Memorial’s Oncology Research Department and Suncoast Communities Blood Bank, which will assist in collecting dendritic cells from enrolled patients in a process called Leukapharesis.
Dendritic cells are a type of white blood cell that rev up the immune system to fight off the cancer and slow tumor growth. In the clinical trial, each patient’s personalized vaccine will be made from dendritic cells and protein taken from her own tumor, at a specialized lab in California. The vaccine, which will be developed while the patient is undergoing treatment, will be administered once a month for six months after treatment has been successfully completed, with follow-up injections later in the year.
For more information about the trial, call Sarasota Memorial’s Oncology Research Department at (941) 917-2227 or visit clinicaltrials.gov
About Ovarian Cancer
The American Cancer Society estimates that each year in the United States, 22,000 women will be newly diagnosed with ovarian cancer, and over 15,000 women will die from it, making it the fifth-leading cause of cancer death in women. When detected early, 90 percent can be cured with conventional surgery and chemotherapy. Unfortunately there is no reliable screening test for ovarian cancer, and just 37-52 percent of patients with advanced disease are long-term survivors.
• There is no known definitive cause. The most prominent risk factor is advanced age – most deaths from ovarian cancer are in women over age 55. Other risk factors for developing ovarian cancer include estrogen-only hormone replacement therapy, a personal history of breast cancer, and a family history of breast or ovarian cancer. Risk of ovarian cancer decreases with the more children a woman has, and the earlier she has her first pregnancy. Oral contraceptives also decrease the risk of ovarian cancer.
• Symptoms of ovarian cancer are often subtle, and unfortunately may not present until the cancer has spread. The most common symptoms will be feelings of bloatedness, pelvic and abdominal pain, and a change in appetite. Other common symptoms often mimic common problems, like digestive symptoms (constipation, gas, nausea, vomiting) and common menstrual complaints (pelvic heaviness, swollen abdomen, vaginal bleeding, weight gain). Unexplained hair growth and sudden changes in genital appearance can also be specific symptoms.
• Treatment of ovarian cancer almost always includes surgery, such as removal of the ovaries alone in cases when it is caught early, but more commonly requires a total hysterectomy (removal of all reproductive organs), and sometimes removal of other abdominal tissues. Chemotherapy is often necessary, and paclitaxel (Taxol) is usually given with carboplatin or cisplatin. Research shows that chemotherapy regimens that contain these drugs are effective in preventing recurrence of ovarian cancer and improving a woman's chance of surviving her cancer. Radiation therapy is rarely used.
About Sarasota Memorial Health Care System
Sarasota Memorial Health Care System is a regional referral center offering Southwest Florida’s greatest breadth and depth of inpatient, outpatient and extended care services, with more than 700,000 patient visits a year. One of the 10 largest public hospitals in America, Sarasota Memorial’s 806-bed acute care hospital has been recognized repeatedly as one of the nation’s largest, safest and best, with superior patient outcomes and a complete continuum of outpatient services– from urgent care walk-in clinics and physician groups, laboratory and diagnostic imaging centers, to home health and skilled nursing & rehabilitation. Sarasota Memorial is the only hospital in the Suncoast region (Sarasota, Manatee, Charlotte and DeSoto counties) ever to make HealthGrades’ 50 best list. For information, visit: www.smh.com