By Erica Steele

After her diagnosis of multiple myeloma in March 2001‚ Kathy Keating Cartwright decided a clinical trial was the best course of action to take because of the possibility of receiving the newest treatment and someday bringing that treatment to others‚ she says.

“There is no cure for my disease now‚ and I want to find one‚” she says. Cartwright‚ 40‚ is one of an estimated 5% of adult cancer patients who have participated in a clinical trial‚ according to the American Cancer Society. Clinical trials test new drugs‚ drug combinations‚ or approaches in therapy. Researchers then compare trial results to standard care in hopes of finding more effective treatment.

There are hundreds of ongoing clinical trials at any given time being offered at institutions across the country‚ and finding a trial for a particular cancer drug presents numerous challenges. After a patient finds a trial‚ either through physician recommendation or individual research‚ they must fit strict criteria based on their disease and treatment history. Once enrolled‚ patients have to figure out travel and cost issues‚ all of which may be for naught if the trial proves ineffective.

Deciding to Enroll in a Clinical Trial
Although cancer investigators have made great strides in recent years‚ it is vital to keep pursuing better treatments‚ says Jim Mulshine‚ MD‚ chief of the Intervention Section at the National Cancer Institute (NCI)‚ Bethesda‚ Maryland. “There’s not a cancer that I know of where the treatment is so good that it doesn’t need improvement‚” he adds.

He says there are no guarantees that a trial will provide better treatment than a patient is already receiving‚ and there is always the possibility of unexpected side effects. But it’s a chance that many people are more than willing to take‚ he says. “They can’t control their cancer‚ but they can control their choices.”
Many patients come to the NCI with advanced cancer‚ having already been treated with existing treatments that failed or having decided to choose a new‚ unproven treatment from the beginning.

“They want the best treatment out there to enable them to have as much meaningful time as possible‚ and at the same time they’re doing something that can help others‚” says Dr. Mulshine.

Cartwright began her search for a clinical trial by calling 800–4–CANCER‚ the NCI cancer–information line available Mondays through Fridays from 9 a.m. to 4:30 p.m. in each time zone. She was directed to the Multiple Myeloma Research Foundation‚ which directed her to some of the top myeloma specialists in the country.

Cartwright and her husband began extensive online research‚ choosing to participate in a clinical trial for Thalomid® (thalidomide) in 2001.

A year later her cancer had decreased significantly‚ and she learned of an opening in a phase II trial testing a myeloma vaccine at the Mayo Clinic. She postponed a planned bone marrow transplant and enrolled in the trial while her T–cell count and energy level were high.

Cartwright advises those considering a clinical trial to first evaluate their own goals and priorities. She notes that everyone’s situation is different‚ and there are no guarantees‚ but there is a chance that you could receive the newest treatment years before it becomes widely available. “I don’t feel like a guinea pig. I feel like a pioneer.”

Cartwright saved hundreds of dollars in hotel bills by staying at the American Cancer Society Hope Lodge‚ located within walking distance of the clinic. Cartwright says she looked forward to seeing her friends at the Hope Lodge during her time at the clinic. “There is an overwhelming sense of camaraderie there‚” she says.

Although being away from her family for weeks at a time was hard‚ Cartwright says the chance of possibly receiving the newest treatment around was worth the extra stress. For those who want to participate in a trial‚ she encourages them to find a way to handle the extra costs and balance the trial with their daily life‚ because the trial could help determine future treatment.
“If this could save me‚ then it could save other people.”

Finding a Trial
Kathleen Shannon–Dorcy‚ RN‚ a research nurse who coordinates clinical trials at the Fred Hutchinson Cancer Research Center in Seattle‚ emphasizes that clinical trials are research‚ not conventional treatment‚ and should not be considered as such. She says that the process of choosing a clinical trial requires clear communication between the patient‚ provider‚ and research team in a number of areas.

• Caregivers know the patient’s needs and condition‚ and must be informed about the trial protocol (set of rules).
  
  
• Outcomes of research trials are unknown‚ so evaluating the uncertainty of the risks and the potential benefits for the patient is important.
  
  
• Physicians may not have access to every open clinical trial‚ so patients should apprise their care providers of any clinical trial options they may discover in their research.

“One of the most important things for patients is to understand their condition and to educate themselves‚” Shannon–Dorcy says. Searching the NCI clinical trials listing (www.cancer.gov) is a good way to find trials‚ she says. This lists all NCI–sponsored trials and also provides links to NCI–recognized institutions and NCI Cooperative Groups‚ where patients can search for trials as well. Once patients learn what is out there‚ they can talk to their physicians about specific trials.

“The more patients understand the implications of their trial‚ the better‚” says Shannon–Dorcy‚ explaining that she refers patients to cancer support groups to find others who have participated in a clinical trial who might offer advice and insight. She also advises them to be sure they have the correct information when discussing a trial‚ such as the trial name‚ protocol‚ and drug manufacturer. Just because trials may sound similar doesn’t mean they are identical‚ and learning all the details is important‚ she says.

Once a patient finds a suitable trial‚ they may begin the enrollment process. Deb Pearson‚ RN‚ an outreach coordinator at NCI‚ says people interested in an NCI–sponsored trial on the campus of the National Institutes of Health in Bethesda‚ Maryland‚ should first call an information specialist (888–624–1937) who takes all the pertinent information‚ including diagnosis‚ history‚ and concurrent medical problems. This helps determine what potential studies exist before the person is referred to an NCI investigator for detailed consideration‚ she says. The investigator goes through the specific trial protocol to determine eligibility.

Trials can be very specific about which patients qualify‚ looking at such issues as prior treatment‚ stage‚ overall health‚ and myriad other factors.

If a patient is eligible‚ the investigator discusses the types of medication and dosages to be used‚ the test schedules‚ and the length of the study. The final step to determine eligibility is an in–person screening visit at the NCI‚ where the patient is formally evaluated for a study.

Before beginning a trial‚ patients go through the informed consent process. By law‚ before agreeing to take part in a clinical trial‚ all participants must be informed about all the details of the trial‚ including the potential risks and benefits. They also learn their rights as participants‚ including the right to information about alternative care options as well as the right to withdraw from the trial at any time.

While most institutions follow a similar enrollment process‚ it is often shortened when a trial is being offered through your physician’s institution. In such cases‚ the physician will know when a patient will fit a specific trial and suggest that he or she take part.

A trial close to home that fits your needs is always the best–case scenario‚ but in some instances‚ travel becomes necessary. In any instance‚ research your options‚ discuss them with your physician‚ and then make an informed decision.