When reporting clinical trial results changed a life

When reporting clinical trial results changed a life

By Stephanie Wykstra, a freelance writer and research consultant for AllTrials USA.

In June 2016, Nicole Gularte was ready to die. The 33-year-old tax accountant had relapsed from Leukemia several times since her diagnosis years earlier. She had lost her hair, could only see in black and white, and her knees hurt so badly that she could no longer turn to hiking and the beautiful vistas of Yosemite National Park for inspiration. Now, she turned her attention to making peace with death, getting baptized, and saying goodbye to her family.

Four months later, the situation reversed: Nicole was in complete remission from Acute Lymphoblastic Leukemia. The turnaround was astounding. But however unexpected, it also came from years of planning, and having the right pieces click into place at the right time.

Following her diagnosis in 2010, Nicole had undergone several rounds of chemotherapy as part of a combination chemotherapy clinical trial, only to have the cancer return. In conversations with her doctors, she realized that after chemotherapy and even a bone marrow transplant, it was likely that her cancer would recur. You’ve got to be kidding me, she thought. I just went through three years of hell. There has to be something better.

A relapse in April 2014 prompted Nicole to do her own research online, searching for clinical trial results on clinicaltrials.gov and other databases. She found that the five-year survival rate for adults with her type of Leukemia who underwent chemotherapy was 25 to 50 percent. She decided to enroll in a trial of an antibody treatment that her doctor (also an investigator) invited her to participate in. At the same time, Nicole was intrigued by a new treatment called CAR T-cell therapy, which was still in clinical trials. CAR T-cell therapy works by engineering a patient’s own immune system so that it recognizes and attacks cancer cells. Nicole found clinical trial results published online, and saw that the early trials were promising.

 “I wouldn’t be talking to you today if the trial results had not been reported.”

Her doctors had mixed responses: One mentioned the possibility of a CAR-T cell trial to Nicole, while another told her to forget about CAR-T, as it would never be a viable treatment in her lifetime. But, Nicole couldn’t let CAR-T go. She was determined to enroll in a trial. In April 2014, she reached out to investigators conducting a trial at the University of Pennsylvania (UPenn), and when they didn’t respond immediately – she kept on calling.

In order to enroll in the trial, Nicole would need to have cancer in her bone marrow, while simultaneously being cancer-free in all other parts of her body including her central nervous system (CNS). (At the time, she was in the reverse state, with cancer in her CNS but not in her bone marrow). The doctors took samples of her cells, so that she might be able to join the trial if she became eligible.

Over the next two years, Nicole kept her sights set on the CAR-T trial. She was so committed that she turned down a matching bone marrow donor, which would render her ineligible for the CAR T-cell trial (by temporarily ridding her bone marrow of cancer). Then more bad news came. Tests revealed there was cancer in her brain, her eyes, and spinal cord. Unless she could clear cancer from these parts of her central nervous system, she wouldn’t be eligible for the UPenn CAR T-cell study.

But then, suddenly and unexpectedly, the cancer receded from all parts of her CNS in July 2016. Everything had lined up for her to join the CAR-T cell clinical trial, and the doctors running the trial agreed to let her join.

In September 2016, she flew to UPenn to start the therapy. The team of doctors was ready for her. After several days, her color vision and strength started to return. Three weeks into the trial, tests showed no evidence of cancer in any part of her body.

By January 2017, Nicole was back to work as a tax accountant. She began flying around the country giving speeches, and in February she accompanied her doctors to an oncology conference (ASH), where they presented the results of the CAR T-cell therapy. While she is still undergoing a long healing process, she is hopeful about the future and looking forward to seeing the one-year results of her trial, when the team announces them (anticipated sometime in summer 2017). She is even looking forward to a day not too far off when she’ll be able to return to hiking in Yosemite.

Nicole believes that having the knowledge of the clinical trial saved her life and all that was made possible by its full disclosure and transparency. “I wouldn’t be talking to you today if the trial results had not been reported,” she concludes. “I was able to research enough to know that the new CAR T-cell treatment was something for me.”

Nicole Gularte is a member of the Emily Whitehead Foundation. To learn more about Nicole’s story , visit her blog, Fight for Cures, and watch this video about the foundation. On July 14, the foundation holds its 3rd annual “Tee off for T-cells” golf tournament in P.A.

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6 Comments

  1. Maria Constantinou

    Amazing story!! I’ve been trying to get my husband into the same trial in Australia since January and still no luck. It’s very frustrating for carers as they can only watch their loved ones deteriorate. My husband was diagnosed with cholangiocarcinoma in May 2015. It’s an incurable cancer and was given only 9 months to live. He’s still with us but began deteriorating 6 months ago and as a result has lost 15kg. He is still fighting and after reading your story I’m definitely going to harass the oncologist involved and try and get him on the car-t trial asap. I just hope it’s not too late ❤️

    Reply
    • Carey Reed

      Thank you Maria for sharing your story. We wish you and your husband the best. Thank you again and take care!

      Reply
    • Joanne

      Hi…try The Alfred Hospital clinical trial centre…that’s where I’m getting mine.

      Reply
    • Nicole

      Hi Maria,

      Thank you for sharing and holding on to hope. I would like to see if I can help you look for a CART trial. Where are you located?

      Reply
  2. Judy Radford

    I too am in Australia Maria and I have asked my On Olivier about this Car-T Cell Therapy and he brushed it aside. I have colorectal cancer which metastasised to my liver. Was NED for 12mths then I found out I have 8 tumours in my peritoneal area. Chemo is killing me and I need a miracle, like all other cancer sufferers!!!

    Reply
  3. Karen van Gorp

    I had agressive stage 4 melanoma in 2013 and when I was found to not have the BRAF mutation my oncologist pretty much wrote me off. I Google at 4am and one night found an early phase report on what was then lambrolizamub. I ended up calling the drug company to track down a trial and I’m still here!!complete response on a very high tumour load.I will forever be grateful that I void access and understand the report.

    Reply

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