Jim Westmoreland’s Path to a Clinical Trial | Aplastic Anemia and MDS International Foundation (AAMDSIF) Return to top.

Jim Westmoreland’s Path to a Clinical Trial

James Westmoreland, age 78, of Cookeville, Tennessee, is a retired Associate Vice President for Information Technology Services from Tennessee Technological University. Here, he recounts his story of how his decision to attend a local blood drive eventually led to his participation in Phase 1 of a clinical trial study at the MD Anderson Cancer Center in Houston, Texas.

How did you first learn about a clinical trial?

Finding out I had a problem happened in an interesting way. I belong to a Kiwanis club and had donated blood off and on, but not on a regular basis. In January 2008, a fellow Kiwanian announced that the Blood Mobile was at the YMCA so I decided to go and donate. They found I was anemic and thus I was unable to donate blood. All my routine medical tests done in October 2007 had been normal. I went to my doctor and blood tests were done -- with abnormalities found, so he wanted me to have more tests completed at Cookeville Regional Medical Center (CRMC) hospital lab.

I went there and more tests were made, all having similar results, so I was next referred to CRMC cancer center – my red and white blood cell counts were low, and my platelet count was found to be very low. They decided to do a bone marrow biopsy right away. A few weeks later, I received the diagnosis of myelodysplastic syndrome (MDS).  This all started just by deciding to go to the blood drive just a month earlier!

In February 2008, I began treatment –receiving azacitidine (Vidaza®) on a seven day treatment that had harsh side effects, so it was cut back to a five day cycle. From that point, over the next two years, I had 25 weeks of this treatment.  I also tried decitabine (Dacogen®), and lenalidomide (Revlimid®), which didn’t work as well so I ended up going back to azacitidine. During this time, I had 92 blood transfusions.

I had planned an out of town trip here in Tennessee, and my doctor said I should not go. Having travel limitations posed a problem because I had been elected to a Kiwanis position that required travel to surrounding states, and had to attend conventions in them. I had one thing going in my favor – I was otherwise healthy. I’m a retired Marine, and stayed in fairly good shape over the decades. I wanted to know what I had to do to be able to travel. We timed the transfusions to occur so that my blood counts would be optimal for traveling.

In December 2009, my doctor in Cookeville referred me to the Sara Cannon Cancer Center in Nashville to discuss the possibility of a stem cell transplant. It’s true that some treatment centers will not consider a stem cell transplant for someone my age. If I had a matched relative donor, they would have done the transplant. But because I was adopted, I have no knowledge of my actual family background. My three children were tested but were not a match. So a stem cell transplant using one of my children as donors was not an option at the center in Nashville, because they did not do matched unrelated stem cell transplants.

The doctor at Sara Cannon Cancer Center had come from MD Anderson to work at the center. He thought MD Anderson would be willing to try matched unrelated stem cell transplant and was willing to make the connection for me.

How did you arrive at deciding to take part in a clinical trial?

We went to MD Anderson in Houston in April 2010 and went through all the testing over a week or more and I was accepted into the stem cell transplant program. They had found two matched unrelated donors for me, but at that point, we did not know if these two people were still available or willing to donate. At this time, they asked if I would consider being part of a Phase 1 clinical trial as an alternative. It did not take a lot of discussion with my wife for us to agree to participate in the trial study, knowing the difficulty that could be experienced with the transplant option, especially at my age.

What were the steps you had to take to apply, be evaluated, and accepted into the trial?

At MD Anderson, once I opted to be considered for the clinical trial, they had me go down the hall to see one of the doctors involved with the trial study. They already had my lab information so some of the evaluation process was already completed. This was more of an interview for the study leaders to decide if I was right for inclusion in the trial. I was accepted, and it was made clear that the stem cell transplant would still be an option for the next six months – this was a good fallback option. This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) will receive investigational study drug ARRY-614.

They wanted to start me right away but didn’t realize I had to take care of things at home first before I could come to MD Anderson for an extended stay. We returned home, made the arrangements we needed, and went right back to Houston. On May 4, 2010, I took the first dosage as part of the study and also received a blood transfusion. For the study, I was taking 1200 mg by mouth (in capsule form) of the ARRY 614 daily. After the first five days, I broke out in a rash! I had an appointment the next day and they decided to take me off the drug until my reaction had cleared up.

As it turned out, an AA&MSDIF Patient and Family Conference was taking place in Houston soon after I started my stay at MD Anderson, so we decided to attend and it was time well spent!  We met other MDS patients and met some of the presenters. By this time, my rash had cleared up. I saw one of the clinical trial team who was speaking at the conference, and he thought it was the dosage amount that had caused the rash. It was cut back to 900 mg and I have been on that dose for over 3 years which is longer than any other MD Anderson patient who is on this trial study medication.

To what extent has the clinical trial affected your daily life?

Related to the trial itself, the follow up visits were first every four weeks, then it was extended to every eight weeks, and now it’s every 12 weeks. So these return trips to MD Anderson have become part of my routine. My blood draws were done locally once a week – now they are every two weeks. I see my local hematologist/oncologist at CRMC Cancer Center every four weeks. So the routine work and evaluations are done locally and the results are communicated back to MD Anderson.

I have not had another transfusion since the one given the day I started with my first treatment. My blood counts are now in the normal range, but barely so. They’re just at the line between normal and low. The platelet counts took the longest to come up to an acceptable level.  As far as the rest of my activity – we still travel, I mow 4 acres and I’m still active in Kiwanis. So this must mean my daily life has not been greatly affected!

What is your advice to patients who are considering or being advised to consider clinical trials as a treatment option?

From my experience, it was taking a chance but many things in life can be like that. We didn’t know if it would help me unless I tried it. Plus having a basis for comparison helps. The original treatment before the trial hadn’t helped me much, although I wasn’t getting any worse. I was just holding the line. But still the counts that I had then were far from normal. So I wanted something that might be better, knowing that a stem cell transplant was a fallback option.

And the decision was easier to make when I realized that even if my treatment in this trial was not successful, I would still be making a small contribution to what is known about this experimental drug and for those it may be able to help. It could eventually help many people!

Would you participate in a clinical trial again?

Based on my experience in this trial, I certainly would. I still feel that even if the medicine had not worked as well for me as it has, it would still have been worth trying because the researchers need to learn as much as possible so they can develop drugs that help many patients in the coming years.

We feel so blessed to have benefitted from this experience. We would like to thank all of those who have been a part of this experience; without them I would not be where I am today.