Jeff Shoop’s Story
Finding the Right Clinical Trial is Key
I’d like to tell you about my journey leading up to the trial, which I feel is an important part of the whole experience. Tenacity, a positive approach, and a willingness to find the best chances are essential in the course of any treatment.
My journey began at my 2 yr CT scan checkup. The scans showed 2 small nodes (about 1/4” diameter) in the right lung. I’ve been told that head and neck cancer recurrence usually shows up around the two-year mark, so having a clean scan at that time period was what we were hoping for. But not this time for me!
My oncologist ordered a biopsy to determine if the nodes were cancerous. The biopsy process itself was fairly straightforward. For me, it was supposed to be an outpatient procedure; however it didn’t end up there. The procedure—to have a small needle inserted into the lung just below my clavicle while awake (in a twilight state)— should have taken about 45 minutes. An interventional Radiologist does the procedure with an assistant and another person reviews the specimen immediately to determine if it’s acceptable or not.
In my case, after they took several samples and removed the needle, my lung partially collapsed. They inserted a chest tube and I was able to enjoy a 3 day hospital stay with twice-a-day chest X-rays. Critically aware of how much radiation was given to me in the first treatment go-around, I was determined to convince x-ray technicians to cover my neck while in the hospital recovering from the collapsed lung. They said it was not the protocol and that it could block part of the lung. I told them they must cover my neck or get out! I never had the same technicians and had to do this twice a day for 3 days until they complied with my persistence. At the end of it all, I was right to insist on what I knew was best for my body. Each x-ray was acceptable.
They determined that the specimens were “inconclusive,” and the hospital thoracic surgeon suggested another biopsy. I told him we would confer with my oncologist, who recommended a 3 month wait to see if the spots got bigger…and they did. So they performed another lung biopsy. This time, going in from the side, they took good specimens and my lung did not collapse! The tests came back as squamous cell cancer (metastatic), and the oncologist recommended a clinical trial, since—in his words—I already had enough radiation. Here’s where the rubber meets the road: My oncologist asked me to research trials and let him know which ones I’d be interested in. I really thought this request was very strange, but I did as asked. He gave me the website (www.ClinicalTrials.gov) and off I went. It was a headache at first because of all the medical terminology. Using keywords like “squamous cell” “head and neck” “recurrence” helped limit the results. If I remember correctly, I believe there were about 70 listed. To point out a very positive aspect, if you do a search now, there are over 200 Head and Neck cancer trials.
Search type of cancer Refined Search State Search Result
Head and Neck 220
Head and Neck Recurrence 18
Head and Neck Recurrence, Squamous cell 10
Head and Neck Recurrence, Squamous cell PA 3
So I did more research. I picked out 7 trials and gave my Dr. the information. A few days later my Dr. called me to go through each one like picking out fruit… “not good… not this one, maybe later…” Better yet, more like the story of Goldilocks and the Three Bears. He selected one and said, “This trial is for you. It’s on the leading edge of research these days. I really believe this is the one to use.” He also said that any of the trials WILL want me because I was asymptomatic (no other health issues other than the cancer) which would be very helpful to the overall statistics.
The trials web site provides many key pieces of information that you’ll need in determining which trial. The hospital and location are a good place to start. Since many trials span from as few as several months to 2 years, it’s logical to first look at the trial location. My trial was listed at Fox Chase in Philly and Johns Hopkins in Baltimore. We also decided to go to Sloan Kettering in New York City as recommended by my cancer buddy Jim Hepfer. I can’t stress enough the importance of having a cancer buddy and reaching out for help. Jim was extremely helpful to us from day one! My coworker Kevin knew about Jim’s cancer and treatment and suggested that I reach out to him. That was a true blessing! Not only did Jim help me during treatment he also took the time from his business and escorted my wife, Lorrie and I to NYC and through the Sloan Kettering review process. Jim is also the one who introduced me to this great support group.
I am naming these key people to highlight the point of reaching out for help. If I had not done so, my options would have been limited, and I would not have had many pieces of non-medical information that many of us need to understand and cope with the whole process. In other words, seek help to feel less in the dark about the process. Never stop looking, never stop asking questions, and never accept unreasonable answers!
At this point, we could begin contacting each treatment center to set up review appointments. It turned out that there were no trials for me at Sloan-Kettering at that time, but we had our first encounter with the review process. Our heads were spinning with all the information. The review process was similar at Fox Chase and Johns Hopkins. We selected Johns Hopkins, because it was an easier drive during the winter months, and the trial was going to last 2 years.
The first thing is to really know all about your cancer history. Know the cancer type, also know the medical terms and know any other specific factors. For me it was;
Head & Neck cancer
HPV P-16 positive
Radiation & 1 dose of Cisplatin, 3 doses of Cetuximab (Erbitux)
Recurrence at 24 month CT scan.
Here are a few of the details that are important to know about before beginning the Trial process:
- Appointment scheduling
- Trial Phase (1, 2, or 3)
- Travel time
- Trial Paperwork (Trial details, HIPPA, eligibility, dose, course of treatment, risks and possible side effects, what is paid for, and what insurance covers.)
- Blood tests
- Review of biopsy – The biopsy chain of ownership is a big deal if the biopsy is done locally.Each treatment center will want to analyze the specimen. So each center needs to providetracking to the original owner of the specimen. If the timeframe between the biopsy and trialacceptance is too long, the protocol may require another biopsy to be done, which is whathappened to me. So they did a THIRD biopsy!
- Trial acceptance
- Begin Treatment
My experience seems to have been unique from the get go. Others have had their oncologists refer them to a cancer research hospital for assessment. Even when we visited Sloan Kettering, the Dr. provided us with hope that they would help us. Since there was no trial for recurrent head and neck cancer at that time, it was left to us to search further. Unfortunately, the Dr. was not forthcoming in pointing us toward a specific treatment center or trial. It was up to us to find one. Again, I found that really strange. I want to stress how important it is to continue to ask questions and seek your own answers. If I hadn’t persevered at this stage, I may have lost the opportunity to be included in the trial that was my best chance for recovery. I am hopeful that this approach has changed and that doctors are now more forthcoming. I am certain that if we stressed this issue with our oncologist, he would have made some arrangement, but it’s unclear as to why he has us do the research.
Once I had decided on Johns Hopkins and provided a blood sample I waited for the call about when treatment would begin. The trial protocol was to begin treatment within 10 days from sign up. Once you sign the document, the clock starts, and they will sign it, noting the exact time it was signed. Dates and times are one of the necessary details of a trial.
Again, my situation went sideways. My coordinator had a family emergency, which delayed the process by 2 days. Then, they couldn’t find a doctor to do the biopsy because of the tumor location. By the time a doctor agreed to do the biopsy, 10 days had gone by. Then the biopsy specimen was sent to the wrong lab, so we lost another 2 days. Unbeknownst to us, I was down to the last day to be included in the trial. My doctor at Johns Hopkins had to personally make a case to the drug company running the trial for me to be included before it closed. Finally, at 6:30 pm Monday night my trial doctor called me with the good news: I was to be at Johns Hopkins the next morning at 7 am to begin the trial. I was the last person in the US to be accepted into the phase 1b trial for the immunotherapy drug now known as Keytruda (It may also be called PEMBRO in the future). The phase 1b trial focuses on the effectiveness, tolerability and safety of the drug dose.
To put this in perspective, I would not have been eligible for phase 2 of the drug trial, which required the patient to have failed at multiple rounds of traditional chemotherapy. This was my best— and only—trial option available at that time. I’ve given you all these crazy details for only one reason. Persistence. Not only on my part but also my Dr. (Dr. Christine Chung) at Johns Hopkins. If she had not pushed the trial leader and the interventional radiologist and the lab, I would not have been in this trial, which turned out to be a lifesaver for me.
My treatment was every 21 days, 200 ml infusion which took approximately 30 minutes. However, drive time, blood test, nurse coordinator meeting and Dr. visit took up a fair amount of the day. The day was even longer every 8 weeks when it included a CT scan.
You’ll meet some amazing people during treatment days; café attendants, hospital workers, nurses, infusion specialists, Dr.’s and other patients. Overall, each treatment day was somewhat routine with few deviations. My Dr now (Dr. Hyunseok Kang) refers to me as the “poster boy” for Keytruda. I was the only one in the Head and Neck trial who had a complete response and made it through the whole trial. The tumors began shrinking after 2 months and had completely dissolved after 9 months. I have been off the trial for 10 months now and all scans have been clear. At my last appointment, September 12, I officially heard the words “In Remission” for the first time. NO CANCER!!!
Please remember, never stop looking for another treatment,
never stop asking questions and never accept unreasonable answers.