July 15, 2005

Moores UCSD Cancer Center Study
Old Drug May Find New Use Against Side Effect of Cancer Treatment

Platinum-based drugs are commonly used in cancer therapy because they have proven effectiveness, but a potentially serious side effect can develop – peripheral neuropathy – for which currently there is no treatment.

Symptoms of platinum-induced peripheral neuropathy include numbness, tingling and pain in the extremities, and can range from moderately troublesome to debilitating. Some patients are confined to a wheelchair as a result of this side effect.

Now researchers at the Moores UCSD Cancer Center are leading a national clinical trial in which an existing drug, Amifostine, is being studied to see if it can reverse symptoms of this side effect and provide relief to cancer patients who have survived their disease, only to find themselves facing a new challenge.

“This is a ‘good news, bad news’ situation,” said the study’s national leader Steven Plaxe, M.D., who is a member of the Moores UCSD Cancer Center and professor of reproductive medicine with the UCSD School of Medicine. “The good news is that we have better, more effective cancer-fighting drugs and more people are surviving. The bad news is that some of these drugs have unfortunate side effects. Peripheral neuropathy as a side effect of chemotherapy is not unusual, and is a growing problem in some patient populations. Unfortunately, we don’t have a satisfactory treatment, which is why this study is so important.”

Amifostine is normally used as a protection of the gums, cheeks and mucosa in the throat during radiotherapy for head and neck cancers. It was originally developed as an antidote to mustard gas in chemical warfare. While researchers don’t fully understand how the drug may work to reverse peripheral neuropathy, there are clues that platinum binds to a part of the neural tissue and Amifostine acts to uncouple that bond.

There are approximately 25 centers nationwide involved in the Phase III study, in which half of the participants, selected randomly, will receive amifostine and the other half will be observed. Those getting the drug will receive three doses a week for 12 weeks and then will be observed for 12 additional weeks. The observation arm will be observed for 24 weeks and then may receive the study drug for 12 weeks if they desire.

Though the study is being carried out under the sponsorship of the Gynecologic Oncology Group, a national consortium funded by the National Cancer Institute, it is open to men and women with platinum-induced peripheral neuropathy from any kind of cancer. The neuropathy must have been diagnosed as significant (Grade 2 or higher) and have been stable for at least three months and not longer than three years. Participants must have completed chemotherapy in order to enroll. MedImmune, Inc. is providing the study drug free to study participants.

For further information call the Cancer Center’s Clinical Trials Office, 858-822-5354.