Can you take us through the timeline from when you had your first tumor removed?
It was prior to 2008, but over the course of the next year, I kept getting infections in the surgical site. And the surgeon kept telling me, “It’s not related to cancer. It’s not my issue. Get it seen by your primary care physician.” And after the third infection, the medical oncologist who was following me called the surgeon himself and forced an appointment. They discovered a mass of melanoma in the deep issue in the same area. So then it was Stage III.
But at the time, there weren’t any options for Stage III. It was just watch-and-wait. So everyone agreed, “Go about your business. We have no idea why it came back like this.” It was kind of a freak occurrence.
That was December of 2009. And then in January of 2010, I became pregnant. The week before I was supposed to go back to work from maternity leave, my oncologist said, “Hey, just because we haven’t done anything since the surgery, let’s do a scan to say you can go back with a clear mind.” We did, and that scan showed that, during pregnancy, it had metastasized to my liver and my pancreas.
When you received the diagnosis in 2011, what was the conversation around treatment?
My medical oncologist, right away, said, “The very best thing I can do for you is to send you to someone else.” He had a screening appointment already set up for me at NCI, thankfully. However, at the time, both my husband and I worked in clinical trial recruitment. My husband was head of the oncology division. So we did have a lot of information that the normal patient wouldn’t have, about clinical trials and understanding them as treatment options, how to access them, and understanding their purpose.
We also consulted with several other melanoma key opinion leaders across the country. It was a time in melanoma where there weren’t a lot of things approved, only high-dose IL-2 and chemo, which is not effective for late-stage melanoma.
For me, it wasn’t really about, “Should I join a clinical trial?” It was about, “Which clinical trial should I join?” That was based on understanding all the potential side effects of all the different immunotherapies that were in trial, because I didn’t want to do something that could give me a long-term side effect that would negate eligibility for another trial, should that one not work.
Was it because you had experience in the clinical trial world, that you knew to think ahead to how potential side effects might affect another trial?
Yes. Not only would a general patient not understand to ask the question about side effects, they would not understand to ask the question about clinical trials at all unless their oncologist brought up clinical trials to them. Only about 15% of non-research oncologists talk about clinical trials to their patients. If that conversation doesn’t happen, then a patient’s not even going to know to look for clinical trials.
The whole reason I got into advocacy work was because, as I was blogging my experience, other patients were contacting me because they had been told by their oncologists [that] there’s nothing else that can be done. I knew as an industry statistic that oncologists do not refer to clinical trials, but I didn’t personalize it, internalize that information until I got the onslaught of requests from other patients, who were desperate to find information on their own. Their doctors had told them there were no options for them without even mentioning clinical trials.
Was the clinical trial appointment your oncologist set up for you the one that you ended up in?
I was screened at NCI. My rationale for wanting to do the NCI trial was, first of all, it was showing the greatest efficacy. The TIL trial shows up to 70% response, and it was the one that would be the most difficult physically to go through. I wasn’t feeling any effects from the cancer. I wanted to hit it the hardest when theoretically I thought I would be feeling my best.
"I didn’t care about what the side effects were; I just needed the best chance of survival because I just had this baby."
Can you walk us through some of the details of the NCI trial?
First, they harvested cells from the tumor in my liver, and they took out all of the lymphocytes that they found in that tumor. They replicated those cells by the billions in the lab. And then, as part of my trial, they genetically engineered those cells to also express interleukin-12 upon contact with tumor. That whole process took six weeks to grow.
In the meantime, they gave me high-dose IL-2 as a standalone treatment. I did respond to that for several months. My last dose of that was in April of 2011. Scans in April, May, June, July showed that everything was shrinking. And then my August scans, all of a sudden, showed 40-plus new subcutaneous tumors.
So at that point, the cells for the TIL trial had grown and were ready. So then in September of that year, I did TIL. It was a month in the hospital, and the first five days were very high-dose chemotherapy to kill my current immune system. They took my cell counts down to zero, and then, once my immune system was completely depleted, they administered the cells that they had created in the lab.
What was next for you?
I had scans every four weeks. My scans in September, October, November and December all showed that it wasn’t working. In December, they really wanted to make another treatment decision. And I just wasn’t ready, so I was asking, “Can we just give it one more month?” And they said, “Okay.”
Then, during that month, I got sick – an upper respiratory infection. My son had it. My husband had it. We all had it. And while I was sick, I could physically feel some of the subcutaneous tumors shrinking. The January scan showed that the tumors had started to shrink. And then they just shrank progressively for the next several years until there was no evidence of disease.
Did they believe that your cold was some sort of trigger?
We think it was the call to action for my immune system. In other TIL trials, they do not genetically engineer the cells to express IL-12. Instead, they deplete your immune system with chemo. Then they give you the new cells and they administer high-dose IL-2 as the call to action for the new cells. But, because in my trial they had genetically engineered the cells, they did not also administer the IL- 2, so theoretically there was no call to action.
Who were the doctors that you were interacting with the most?
NCI is a teaching hospital. There’s the head of the surgery branch, which is Dr Steven Rosenberg. Then there’s his group of four attending physicians, who are consistent on-staff positions dedicated to that branch but they rotate in their patient duties. There’s also a group of fellows, who are your primary point of contact. When I was inpatient, I saw Dr Rosenberg, the attending physician, and the fellows every single day. One of my nurses has a daughter the same age as my son, just a week apart. She was very empathetic because she saw me put pictures of the baby on the wall, and we became good friends.
"You have to make sure you’re advocating for yourself; you have to gather all the information you need."
You took something very special to your screening appointment. What was it?
They make the treatment decisions on which trial you should do and if you’re eligible by committee during their Monday meetings. I knew that. To my screening appointment, we took a picture of me and my newborn, and gave it to my fellow and asked him to take it with him to the meeting. To show everyone that I didn’t care about what the side effects were; I didn’t care what was going to happen. I just needed the best chance of survival because I just had this baby.
When we were checking into NCI for the first time to do IL-2, the nurses kept coming in and saying hello to us. They knew our names; they knew the baby’s name; they knew our story. The nurse came in and we asked, “Is this normal? Do you just always know everything about everybody who comes in?”
She said no. The doctors had walked the picture I gave my fellow around the floor the day before, and had said, “This woman is checking in with us tomorrow and we’re going to save her life.”
What was it like being on IL-2?
IL-2 works by eliciting a full-body immune response in the hopes that your immune system will stumble upon a tumor and attack it. The side effects that I experienced included copious amounts of vomiting and diarrhea; my skin from my forehead to my shoulders peeled off four times. I had full-body rashes; terrible itching. I gained 25 pounds of water weight in four hours, all four times, which causes your skin to crack open. I had hallucinations; I had horrible nightmares that lasted for a couple of years. The first time, after I was finished dosing, it hurt so badly that I could not open my eyes for two days. You get terrible rigors. Your body just shakes uncontrollably, and you’re freezing from the inside and you can’t get warmed.
Do you think we’re in a different time around including clinical trials as a care option?
Patients are increasingly more self-advocating around healthcare issues and will do more research and will find the resources they need. And they will ask questions. As patients are increasingly more comfortable with pushing back on their initial healthcare providers and asking the hard questions that are needed, getting second opinions and going to specialists in the disease area, they’re more likely to come into contact with clinical trial resources. You have to make sure you’re advocating for yourself; you have to gather all the information that you need. If you don’t know how to do that, you need to find out how to do it.
Is there anything you’d like to end with?
The only way patients can join clinical trials is if they know about them, and they only know about them if information about them is available where they’re searching in ways that they can understand. We, patients, desperately need more emphasis on clinical trials as viable treatment options, especially for life- threatening illnesses like cancer.
For more information on Patients as Partners, visit patientsaspartnersconference.com.
