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Washington, D.C. — Researchers at the Lombardi Cancer Center at Georgetown University Medical Center are recruiting patients with newly diagnosed, stage III ovarian cancer for a clinical trial that will administer standard chemotherapy along with a new experimental drug, known as IM862, that can be self-administered as nose drops.
The Lombardi trial is part of a nationwide clinical trial to evaluate the safety and efficacy of IM862 (glufanide disodium), which has been tested on more than 400 cancer patients in clinical trials in the United States, Canada, Europe and Australia. Preclinical studies suggest that IM862 stimulates the body's immune system and inhibits the development of blood vessels that tumors need to grow and spread.
"While this new therapy is still in the trial stage and not widely available to patients with ovarian cancer, the preliminary results are very encouraging," said James Barter, MD, professor of gynecologic oncology who is conducting the trial at Lombardi. "The side effects tend to be much milder than those of traditional chemotherapy. In addition, this trial will evaluate whether IM862 can add to the anti-cancer benefits seen with chemotherapy."
According to the American Cancer Society, more than 23,000 new cases of ovarian cancer are diagnosed each year, and about 14,000 women in the United States die every year from the disease. If the cancer is found and treated before it spreads beyond the ovary, the five-year survival rate is 95 percent-but only 25 percent of ovarian cancers are found at this early stage, according to the American Cancer Society.
Most women with stage III ovarian cancer-which means that the tumor has spread to the lining of the abdomen or to the lymph nodes-initially achieve complete remission with surgery and standard chemotherapy. However, many patients relapse over time. The purpose of this study is to determine whether the addition of IM862 to standard chemotherapy results in longer-term remission of patients' cancer, with little or no additional toxicity.
IM862 was developed by Cytran Inc., a privately held biopharmaceutical company headquartered near Seattle, which is funding these studies. (For more information about Cytran, visit
www.cytran.com.) This clinical trial will involve a total of 180 women with stage III ovarian cancer at 15 to 20 medical centers across the United States.
To qualify for this clinical trial, participants must be 18 or older and newly diagnosed with stage III ovarian cancer. They must have undergone successful surgery to remove their tumor and must not have received prior treatment for their cancer. Patients will be randomly assigned to one of three arms of the study, each with a different dose of IM862, while undergoing conventional treatment of six cycles of chemotherapy. Patients who show little or no evidence of disease after receiving treatment will continue to receive IM862 for an additional 24 weeks. The trial will be double-blinded, meaning that neither the doctors nor the study participants know who is receiving what dosage.
The study's primary objective is to determine the safety and efficacy of IM862 when it is given with chemotherapy and to determine if IM862 increases the percentage of patients with no evidence of disease at "second look surgery." Secondary objectives include the evaluation of occurrence of infection or other complications, length of remission and the ability of IM862 to decrease tumor blood supply and stimulate the immune system.
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