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Baylor studying gene therapy for ovarian cancer
Houston, Texas -- For the first time, gene therapy will be combines with surgery and chemotherapy n a clinical study for treatment of recurrent ovarian cancer.
The U.S. Food and Drug Administration recently approved the study, which will take place at Baylor College of Medicine and the Methodist Hospital in Houston.
"Mice with ovarian tumors were cured through our approach to gene therapy, and we're hopeful that the combination of gene therapy with surgery and chemotherapy will improve current treatments for ovarian cancer in humans and decrease its recurrence," said Dr. Dirk Kieback, associate professor of obstetrics and gynecology at Baylor and an attending physician at Methodist.
Participants in the study will undergo abdominal surgery to have recurrent ovarian cancer removed and to have two small catheters implanted. A solution containing a modified adenovirus will be poured through the catheters to coat ovarian cancer cells.
This adenovirus will carry a gene that makes cancer cells susceptible to acyclovir, a drug commonly used to combat herpes virus infections. Acyclovir will be given to patients intravenously for two weeks after they have received the solution containing the adenovirus.
Other studies with similar adenoviral vectors, or vehicles, to transport this gene for cancer treatment have used ganciclovir rather than acyclovir. The Baylor/Methodist study is using acyclovir because it is less toxic and might allow for a higher dose.
"With a higher dose of acyclovir, we can increase the intensity of gene therapy without exposing the patient to dangerous side effects," Kieback said. "We want to find the maximum dose of gene therapy that is safe, so we will monitor patients for signs of toxicity.:
In combination with gene therapy, patients will receive the chemotherapy drug topotecan. "This drug has shown promise in the treatment of recurrent ovarian cancer and appears to be even more effective when used in combination with gene therapy," Kieback said.
Patients in the study will receive six treatments of topotecan over four-week intervals to minimize the risk of cancer recurring.
About 36,000 women die from ovarian cancer each year. The disease affects one in 75 women, but it accounts for more deaths than any other gynecological malignancy in women, Kieback said. Symptoms can include an expanding abdomen, a feeling of fullness in the pelvis, fluid in the stomach and indigestion caused by bowel obstruction. The disease is often diagnosed late, resulting in poor survival rates.
About 30 percent of women with ovarian cancer survive for five years or more. A family history of breast or ovarian cancer can increase a women's chances of getting the disease.
Twenty women are needed for the study, which is funded partially by Baylor College of Medicine and The Methodist Hospital. The standard treatments costs, including surgery and chemotherapy, must be paid by participants or their insurance company. Methodist will cover the costs of the gene-therapy treatment. To enroll, women with ovarian cancer should call (713) 798-7675 or have their physician call.
Kieback's co-investigators for the study are Dr. Estuardo Aguilar-Cordova, assistant professor of pediatrics at Baylor and director of the Cell and Molecular Therapy Laboratories at Baylor and Texas Children's Hospital, Dr. Alan Kaplan, Baylor professor of obstetrics and Gynecology and medical of gynecologic oncology at Methodist, and Dr. Xiao-Wen Tong, Baylor instructor of obstetrics and gynecology.
