Clinical trials — providing hope for tomorrow

382

Thirteen months ago, Ruth Rogers was given less than a year to live. Living with advanced stage colon cancer, Ruth had exhausted all standard treatment methods and her cancer continued to worsen.

While visiting the Hamilton Regional Cancer Centre (HRCC) in June 2002, she was told about a clinical trial that she thought offered her some new hope. With nothing to lose, Ruth agreed to speak to clinical trials nurse Susan Polawski, who filled her in on all the details of a new study for an investigational drug being tested on patients with advanced or recurrent solid cancers. The drug is developed from the Newcastle Disease Virus, a type of virus that infects birds that is commonly referred to as the “chicken virus.”

By participating in clinical trials patients are accessing a special form of cancer care. Clinical trials provide people with access to new therapies that may take many years to be approved as an accepted treatment. Patients enrolled in clinical trials are closely monitored and often have to undergo more routine tests during the study. There are 95 trials spanning every disease site currently active at the HRCC.

“The outcomes of clinical trials contribute new knowledge that may lead to increased survival rates for a particular cancer, better control of the disease or increased quality of life for patients,” said Dr. Jim Wright, Head of Clinical Trials at the HRCC. “Although there are no guarantees that any new or standard treatment will work, patients enrolled in clinical trials are among the first to potentially benefit from new discoveries.”

Agreeing to participate in a clinical trial is a complicated decision for patients. Of the HRCC’s approximately 7,000 new patients last year, over 400 people went into clinical trials.

A family history rife with cancer, and her own desire to live made Ruth’s decision to participate in the “chicken virus” trial very easy.

“I wasn’t ready to die and this trial gave me hope. If there is anything I can do to help protect my son and others from this disease, then I’ll do it,” said Ruth.

Clinical trials are carried out in three phases that study different aspects of the treatment before it can usually be approved as a standard treatment. Phase 1 trials are the first step in testing a new treatment in humans. Because of their highly experimental nature, Phase 1 trials are usually limited to a small number of people with advanced disease who have exhausted all conventional treatment methods. Depending on the success of each phase, a study will progress through the phases, involving more people across more cancer centres.

The HRCC is the only cancer centre in the world offering this trial – Ruth and 17 other people were the first to receive this drug.

As Ruth will tell you, one advantage of participating in this trial was new friendships. All study participants received treatment in a separate area of the chemotherapy suite they affectionately referred to as the “chicken coop” – they even adorned their area with ceramic and bobble-head chickens. Because the drug dose is administered over a three-hour time period, many study participants in the “chicken club” spent a lot of time together and became an invaluable support for each other.

The Phase 1 trial for the “chicken virus” is complete and not accepting new patients. The results for all the involved patients must now be reviewed and summarized. Based on these results, the pharmaceutical company may design a Phase 2 study, which may bring this therapy one step closer to standard practice. However, the answer to whether or not the use of the “chicken virus” will ever become a standard treatment is years away.