NEW YORK, Jun 29 (Reuters Health) -- Women who are newly diagnosed with ovarian cancer may be candidates for a study testing an experimental gene therapy, according to investigators at the University of California, Los Angeles.
In an earlier trial, about a third of patients experienced a 50% or greater reduction in tumor size or a reduction in CA-125 levels, a marker of cancer activity, when given the gene therapy compared with women not given the treatment. CA-125 is a protein elevated in the blood of women with ovarian cancer.
That study, a "phase I" trial of a drug, was conducted in women with advanced ovarian cancer to determine if the treatment was safe.
Those "results were really provocative," said investigator Dr. Mark Pegram in a statement issued by UCLA. "We didn't expect to see such positive findings in patients with advanced disease that had not responded to surgery or chemotherapy," Pegram said.
"I call this the 'new oncology,'" Pegram added. "Cancer is caused by mutations in the genes of normal cells. So if you want to successfully treat cancers, you should develop drugs specifically to fight the mutations involved."
The researchers are now seeking volunteers newly diagnosed with ovarian cancer to participate in an international trial of the gene therapy.
In the trial, a genetically engineered respiratory virus that carries a p53 gene will be periodically infused into the abdominal and pelvic cavity. The p53 gene is a tumor suppressor that is mutated in many different types of cancer, including 57% of ovarian cancers.
The study is designed to test if the engineered virus will infect the ovarian cancer cells, restoring p53 gene function. The virus may cause flu-like side effects such as fever, fatigue, or stomach upset.
Patients in the trial will be randomly assigned to chemotherapy alone or chemotherapy plus p53 gene therapy. Those interested in the trial can call (310) 825-8375.
