by Amy Phariss

One OutreachNC Magazine reader and friend explains his journey into the world of clinical trials and offers tips for anyone traveling a similar road. 

On a quiet afternoon in late winter, a tall, slender man knocked on the door of my office, shook my hand and handed me a folder of information. All of it was related to the world of clinical trials. For the next hour, we discussed his own cancer diagnosis, his treatment and his ultimate decision to search for and pursue a clinical trial. During that hour, we discussed all matters of the clinical trial process including the initial feeling one has when faced with a diagnosis of cancer, how to go about researching and finding clinical trials and what it’s like to pack up, travel to another state and face a medical team tasked with assessing your eligibility for access to a potentially life-saving drug. 

The conversation left me informed, curious and humbled. I entered a new world, one that gave me a window into the experience of dealing with a life-threatening illness and facing the possibility that current drug therapy might fail to cure that illness. I am indebted to Mr. Coleman for his willingness to discuss an incredibly personal area of his life so that we all might better understand a process that is often confusing, opaque and difficult to manage.

This interview has been edited for length. 

Amy Phariss:  Can you tell me about your cancer diagnosis?

Mr. Coleman:  In December of 2013, I was diagnosed with myelodysplastic syndromes (MDS), which is a form of
cancer that affects the bone marrow and inhibits the production of mature blood cells in the bone marrow. I was treated with a first-line drug for this particular type of cancer. The doctor told me I had 6-12 months, which was of serious concern to me. 

AP: What was your first reaction when you were diagnosed?

Mr. C.: That we were going to start on this drug and hope for the best. I was totally shocked when the doctor told me 6-12 months. I was anxious to proceed with my treatment. 

AP: What is a first-line drug, and how did you respond to that medication?

Mr. C.: A first-line drug is the initial treatment for MDS. It’s the one generally accepted as the best treatment for a specific diagnosis. I went over four years on this drug before it became ineffective, which is determined by taking a sample of bone marrow and measuring the percent of cancer cells in the bone marrow. 

AP: What happened when that happened? When the first-line drug became ineffective? 

Mr. C.: There is a second-line drug that is approved by the FDA. For my particular situation, only two drugs were approved by the FDA for treatment. I went 4.5 years on the first one, and I started the second one last July. I was hit very hard with the major symptom of fatigue, overall tiredness and low blood counts. This is the nature of that drug; it attacks the blood counts in your bone marrow as well as
the cancer. 

My local doctor said, “I don’t think this drug is going to work for you, and I think you should go find a clinical trial. The best source of information will be the internet.” 

AP: What did you do? Did you begin searching the internet?

Mr. C.: Well, I had my son help me. He works a full-time job and lives up north, but he was able to help me. He was a huge help. The major source that my son found for clinical trials online is the National Institutes of Health (NIH – www.nih.gov and www.clinicaltrials.gov). They have a huge database. You put in your information and the website searches for the clinical trial that will be adaptable for your situation. We learned that all of the major cancer centers conduct clinical trials. And many of these centers actually have clinical trial counselors, navigators who can answer questions and guide you through the process. We didn’t know that when we started searching, and that would have been helpful, to have a navigator. All you have to do is call a phone number and speak to somebody live, and they help you find a clinical trial. You don’t even have to be a patient at the facility, which is a wonderful service. 

AP: Once you found a trial, how did you go about taking the next steps?

Mr. C.: Well, you can just call up the cancer center where the trial is being conducted, but I got a referral from my doctor. I had to fill out all kinds of application papers. The doctor had to sign off with medical records. 

AP: Where was the best location for a clinical trial?

Mr. C.: In Houston, Texas at MD Anderson Cancer Center. 

AP: That’s far away. Did it take long for all of the paperwork and to make the appointments? 

Mr. C.: The whole process took two weeks to gather the records and send them down there. They are very efficient and move very quickly at MD Anderson. I don’t know about other locations, but you don’t sit around and wait three months for an appointment. You have an appointment almost immediately. They consider that new patients coming to MD Anderson have an urgent situation. So, I made arrangements to go to Houston and be evaluated. It’s a long trip, and my son (who’d done all the research) went with me. 

AP: So, you didn’t just show up and join the trial? You had to
be evaluated?

Mr. C.: Yes. At MD Anderson I wasn’t being evaluated for a specific clinical trial. They take all of your particulars, and if they think a clinical trial is in order, they recommend one. They run a lot of tests that first day. They even took a bone marrow sample that day. They call all the testing ‘genetic mapping.’ The patient has to depend on the medical professionals for advice, on clinical trials and on cancer clinics, where you go to be evaluated. You can’t just pick it off the internet, so to speak. You can’t just decide you want to go close to home or something. You’ve got to be evaluated. They’re going to run tests, and then they’ll recommend what’s best for your specific type
of cancer. 

AP: That sounds extensive and… expensive. 

Mr. C.: Absolutely. But Medicare covers a lot of it. The billing to Medicare for my evaluation was substantial. Medicare, which is my primary health insurance, and my secondary health insurance picked up the bill for that. But there is a cost to being part of a clinical trial. If you agree to enter the trial, the protocol for the trial requires that you come to the location for treatment. You cannot, for instance, farm the treatment to another hospital closer to your residence. The facility conducting the trial has to administer the drugs. They have to be sure that what you’re getting is what you’re supposed to get. So, if you have to go down there once a month, say for five days to have treatment, you’ve got to pay for it – the travel and expense of that. So the patient must have some financial means to participate in these trials. As you can imagine, it can get pretty expensive if you get into a trial and have to go regularly for treatment. 

AP: After the evaluation and trip, what was the conclusion?

Mr. C.: After all the detailed testing, the conclusion was that I should continue on the second-line drug, evaluating that drug on a very specific schedule that they set up, at a specific dose that they recommended. They did not recommend a clinical trial at that time. They felt it was worth evaluating the second-line drug under their recommended dosage, which was different than what I’d previously been given. I have just completed the third cycle in their recommendation, and I’m scheduled to have the biopsy soon, which will tell if the drug has been effective. 

AP: What then? What if it had not been effective? 

Mr. C.: I’ll go back to M.D. Anderson because they made the initial recommendation on what to do. I assume they would recommend a clinical trial. It may be that they say, “Well, Mr. Coleman, you’ve evaluated the second-line drug and it was ineffective but we don’t see a clinical trial that would be a good fit.” My son found 42 clinical trials for my particular situation. So, there’s an awful lot out there. 

AP: Did you ever feel frustrated or overwhelmed by the process of identifying a clinical trial?

Mr. C.: Not yet. There may be a day, but I’ve been very fortunate to have a good navigator in my son, and we’ve been fortunate to find other good navigators at MD Anderson. I’m sure if I’d tried to do all this myself, it would have been very frustrating. 

AP: Have you ever felt discouraged in this process?

Mr. C.: Yes. I was expecting and hoping that I would get into the clinical trial and I would not have to continue with the particular drug I was taking. I felt, probably with no facts, that the clinical trial would be more beneficial. But I accepted their recommendation. But I’m hoping for a clinical trial because of the way this drug has treated me in terms of extreme fatigue and low blood counts. It just really hammered my system. It’s the nature of the drug; it’s the way that it works. You just have to compensate for it. Maybe a drug out of the clinical trial will be the same thing. Who knows? I think it’s great that the clinical trials are available as a treatment option. 

AP: Finally, Mr. C., is there anything you wish you’d known
going into this process or could share with someone facing the
same experience? 

Mr. C.: I wish I’d had the opportunity to talk with a clinical trial navigator to explain all the particulars that I’m relating today. You must be your own best advocate and be aggressive in seeking out the relevant information currently available for your specific type of cancer. Work with your doctor and other medical professionals to make the appropriate contacts in finding a navigator at cancer centers and hospitals. All top-rated cancer centers, major hospitals, and universities have clinical trial navigators available for consultation. 

Ask Questions:

  • What is the main purpose of the study? Is it to study a new drug, to identify the cause of a disease, or to improve comfort and quality of life for chronically ill patients?
  • Why do researchers think the approach/medication might be effective?
  • What are possible risks/benefits, both long and short term?
  • What kinds of therapies, procedures and/or tests are included during the trial?
  • What are the chances of a beneficial outcome?
  • What are the known side-effects of the treatment/drug and are these side-effects permanent?
  • How long does the trial last?
  • Will enrolling in this clinical trial limit my ability to enroll in another?
  • Does this trial involve a ‘control group’ and the possibility of receiving a placebo?
  • What group does the study focus on? Is it specific to my condition or broader in scope?
  • What are the costs associated with the trial (medications, testing, lodging, travel, etc.)? 
  • How much of the cost will I incur?

Cover the Cost:

Resources exist to assist people in covering the costs of clinical trials, including additional testing, travel, childcare costs and other expenses. Here are seven organizations providing support: 

1. 21st Century Care – provides patients financial assistance for incidental expenses related to cancer treatments. www.21stcenturycare.org

2. CancerCare – offering limited financial assistance for cancer-related costs and co-pays. Oncology social workers available to assist in finding other resources. www.cancercare.org

3. PAN Foundation –  using donations from private donors and corporations, PAN helps patients with out-of-pocket costs. 
www.panfoundation.org 

4. Patient Advocate Foundation –  provides support, information and funds (grants) for patients who meet financial and medical criteria.  www.patientadvocate.org

5. Cancer Financial Assistance Coalition – a coalition of organizations helping cancer patients meet their financial challenges including direct medical costs, non-medical costs and daily living expenses. www.cancerfac.org

6. Cancer Finances – provides a toolkit for navigating finances before, during and after cancer treatment. www.cancerfinances.org 

7. HealthWell Foundation – helping the uninsured/underinsured afford medical treatments for chronic or life-altering diseases. www.healthwellfoundation.org