Kicking Cancer – 8th Time

Today marks the first day for my new treatment plan. My mom flew out on her birthday (October 28th) from California to be with me through this next journey. Fortunately, we were able to spend some time together before checking into the hospital just yesterday.

Since my previous treatment in 2016, CAR T 19 gained FDA approval and has saved hundreds of children all over the world. Just after the news of my latest relapse, a brand new clinical trial opened just in time – a CAR T 22 clinical trial. Although very similar to CAR T 19, CAR T 22 is a brand new trial and I will be the first patient – in fact, my doctor and I had to wait 20 minutes for the FDA to open/accept the trial before signing.

We are both excited and a little nervous for this new CAR T clinical trial. My doctor said the side effects of this CAR T 22 trial should be similar to that of my last CAR T 19 trial. The treatment was a success; however, I had very high fevers and some small seizures – which is good because it means the T cells are fighting the cancer. With such high fevers (105.8 degrees for six days), I do not recall anything that occurred over that period. Although a bit scary for others who surrounded and supported me during that period, CAR T proved to be very successful in that I was able to achieve remission in just 28 days – and this was shortly after being placed on hospice with just three to five weeks to live. A miracle indeed!

Shortly after mom arrived at the hospital today, Father George popped in from the local Catholic Church. After talking and laughing a bit with my mom and I, Father George proceeded to give me an “anointing of the sick” and said he would be around during my stay here in the hospital. Nothing feels better than putting all my worries in God’s hands, for he has carried me all this way for a reason. Although I may not know the reason or purpose, I am fortunate and very grateful to have this opportunity.

This treatment regimen begins with five days of chemotherapy, followed by my T cells. I am scheduled to receive my new T cells on Wednesday, November 7th. After the infusion, we will wait for “the storm” to take place.

Physical therapy came by and brought me a nice stationary bike to ride in my hospital room. With the best views from the 6th floor, I look forward to exercising while I am still feeling well.

I look forward to sharing updates!

This video is a reminder of the heart of my inspiration 🙂

Fire with Fire – Emily Whitehead

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CELL THERAPY

Survivor: This Woman’s Battle With Leukemia Is Pointing The Way To The Future Of Healthcare

Nov 22, 2017 by Kristin Kloberdanz & Bruce Watson

In the spring of 2016, 32-year-old Nicole Gularte grew weak and lost her ability to see colors from her left eye. She knew that her leukemia had returned.

Gularte’s form of the disease was called acute lymphoblastic leukemia, or ALL. She had been in an exhausting on-and-off battle with cancer for six years, and she was desperate to avoid yet another debilitating round of chemotherapy. She wasn’t particularly thrilled when doctors told her they had gotten lucky and found two nearly perfect bone marrow matches. Long-term studies have shown that nearly half of leukemia patients who receive a bone marrow transplant die or relapse within two years.

The story of what she did next offers a fascinating look into the future of cancer treatment. She rejected the transplant and opted to let the relapse of her ALL take full hold. That allowed her to enroll in a clinical trial of a promising new cancer treatment called CAR T-cell therapy that was run by the University of Pennsylvania and Children’s Hospital of Philadelphia. “I called UPenn,” Gularte says. She made her circumstances clear to the doctors, telling them: “I’ve given up a 10-out-of-10 bone marrow transplant so I can relapse so I can qualify for your CAR-T trial.”

In cell therapy, doctors remove some of a patient’s T-cells, the immune cells that fight against infection, reprogram them to fight and kill cancer, then put them back into the patient. Developed by doctors at Children’s Hospital of Philadelphia, the treatment gained prominence after it saved a young girl named Emily Whitehead in 2012. It’s had a 93 percent success rate in trials with patients with advanced leukemia, but it’s still a very new type of therapy. A refined version of the treatment that saved Whitehead, now called Kymriah and made by Novartis, was the first CAR T-cell therapy approved by the FDA, which in August cleared it for use in children. In October, the FDA approved a second version of CAR T-cell therapy, called Yescarta and made by Kite, to treat b-cell lymphoma for adults.

Gularte next to University of Pennsylvania’s Dr. Carl June, a leading cancer researcher. Image credit: Nicole Gularte.

Most other, similar versions of the treatments are still in the testing phase. But this new form of treatment is a welcome alternative to patients who, like Gularte, find chemo dismaying and bone-marrow transplants too uncertain. “I realized that if there was a chance of something better out there, I needed to research it and come up with my own decision,” Gularte says.

The University of Pennsylvania’s adult cell therapy trials proceeded haltingly until they gained momentum in 2016, just in time for Gularte. She gained admittance to the program, and on September 7, she received her modified T-cells. Doctors had previously removed them from her body, modified them with a virus to recognize her cancer, multiplied them and transfused them back into her body.

She spent the next few days wracked with 105.8 degrees Fahrenheit fever and suffering from several seizure-like episodes as the T-cells started fighting her disease. But her temperature soon lowered, and, on the tenth day, something surprising happened. Her eyesight, which had deteriorated during her fight with leukemia, returned.

“I was half blind in one eye, and totally color blind,” she recalls. “Then, while I was watching TV, I noticed that the girls on the screen had bright green skirts.” When she had her color vision tested, she scored 13 out of 15. Soon, her T-cell levels, which plummet when leukemia patients are battling the disease, returned to normal. She was released from the hospital.

A year later, Gularte’s T-cell activity is elevated, but she is still in remission. She’s become a passionate advocate for CAR T-cell therapy. The University of Pennsylvania’s cell therapy trial is one of more than 800 studies in gene and cell therapy currently underway globally. And based on the 80 percent complete remission rates of these trials, experts anticipate that cell therapy is poised to become a major means for fighting cancer.

Top: In 2016, Nicole Gularte entered a cell therapy trial run by the University of Pennsylvania and Children’s Hospital of Philadelphia with the hopes of fighting her acute lymphoblastic leukemia. It worked, and today her cancer is still in remission. Image credit: Nicole Gularte. Above: GE scientists and others are working to accelerate the manufacturing processes of such cell therapies at the Center for Advanced Therapeutic Cell Technologies in Toronto. Image credit: CCRM.

Tens of thousands of patients per year could be receiving the treatment by 2024, and by 2030, the cell therapy industry is expected to be worth an estimated $30 billion.

While these emerging therapies bring new hope, the process to manufacture them can be lengthy and expensive, and producing enough to meet potential demand is challenging. “Now we need to help make cell therapy affordable and scalable,” says Phil Vanek, general manager for cell therapy growth strategy at GE Healthcare Life Sciences.

GE’s cell therapy business and others are racing to provide technology and processes to make that happen. In collaboration with Center for Commercialization of Regenerative Medicine (CCRM) and the Federal Economic Development Agency for Southern Ontario, they’ve embraced a new cell therapy research and process-development facility called the Center for Advanced Therapeutic Cell Technologies, which officially opened this September in Toronto. Designed to help pharma companies, university researchers, startups and technology companies scale up manufacturing faster, the new center already employs a team of more than 30 biologists, virologists, and biomedical and other engineers, from both GE and CCRM.

“We’re transitioning into the future,” says Gularte. “It’s not just about traditional drug discovery anymore, it’s now about the innovative life sciences industry, and the ways that doctors are learning to work with the body. Cell therapy could potentially eradicate many diseases. I wanted to be part of that.”

The Emily Whitehead Foundation

kari-em-and-tom

Kari, Emily and Tom at the NYC Gala, 2015


A GIFT OF INSPIRATION

The Emily Whitehead Foundation (EWF) is a nonprofit company organized by Tom and Kari Whitehead on behalf of the treatment that their daughter, Emily, received in 2012.  Emily is the first pediatric patient to receive CAR T-cell therapy.  The foundation’s purpose is to raise money and awareness for childhood cancers and cancer research.  I was first diagnosed with children’s Acute Lymphoblastic Leukemia in 2010.  Facing more relapses and less options, I began to research T-cell therapy.  Emily has been my hero for nearly three years – since I first watched her T-cell story in the YouTube video, Fire with Fire, by Ross Kauffman.  Her story has kept me inspired and has given me the courage to keep fighting for T-cell therapy and awareness.  


CHALLENGES

During my struggle to gain access to CAR T-cell therapy at The University of Pennsylvania, I faced several problems that included:

  • Disqualification from the study
  • Discouragement and loss of hope
  • Loss of travel funds

FIRST CONNECTION

I first reached out to Tom in July 2016, in an effort to obtain guidance from an expert in patient care and advocacy with T-cell therapy.  Although I qualified for the CAR T-cell trial in April 2016, I experienced a relapse in the central nervous system (CNS) which immediately disqualified me from the study.  After six years of battling ALL coupled with another relapse, I began to lose hope.  I chose to reach out to the EWF, because I knew Tom and Kari Whitehead would have a great deal of knowledge and experience in T-cell therapy and patient advocacy.


SUPPORT PROVIDED 

  • Reliable source of contact
  • Patient advocacy
  • Prayer
  • Assistance with travel arrangements

SHARING AND CARING

In early August, I explained to Tom that I no longer qualified for the trial, and that I was tired of fighting.  I stopped all treatments and a Stanford pallative care team had given me three to five weeks to live.  Tom told me not to give up and said that things would fall into place.  He assured me that he and the EWF would continue to help get me out to Philadelphia for treatment. His words eased my fears and frustration.  He helped me regain focus and get back on track in my efforts.  The EWF community added me to prayer lists, while Tom made dozens of phone calls in an attempt to get me out to Philadelphia.  Tom advocated on my behalf, stood up for my rights, and encouraged me to reach out to others who once faced similar situations.

After a trip back to Stanford per Tom’s recommendation, doctors confirmed a miracle – my blood looked normal and my spinal resutls showed no leukemia cells in the CNS.  At this point I had not received chemotherapy or blood transfusions for several weeks, so it is very unusual that my labs would look so good.  This meant that I qualified for the T-cell therapy trial.  Tom immediately put me in contact with someone who quickly arranged flights for me and a friend.


OUTCOME

  • Received T-cells
  • Cancer free
  • Future advocate

WITH GRATTITUDE

I am most grateful to the Whiteheads for coming into my life during my time of need.  The EWF community restored the hope I once lost and they showed me what it was like to believe all over again.  The Whiteheads were instrumental in getting me out to Philadelphia for the CAR T-cell treatment.  The EWF’s  community had a major impact throughout my CAR T-cell journey at The University of Pennsylvania.  If not for them, I would not have received my treatment.


ABOUT THE EWF 

The EWF has created a vast community – connecting patients, parents, fighters, survivors, and supporters who help patients and families involved with T-cell therapy.  The foundation has a team of individuals who have come together to help inspire and create a brighter future for children, patients, and families.

SUPPORT FOR OTHERS

The EWF offers an array of services that can benefit patients and families who need help with:

  • T-cell therapy information
  • Sharing experiences
  • Encouragement
  • Community support
  • Awareness
  • Patient advocacy
  • Resources
  • Cancer research

HOW TO HELP

The Emily Whitehead Foundation is dedicated to raising awareness and funds for T-cell related therapy.  You can help by participating in a fundraising event or by donating.  For more information, you can visit the EWF’s website:

The Emily Whitehead Foundation 

OTHER RESOURCES

See T-cells in action!

Fire With Fire Video with Dr. Carl June

Follow Nicole and other patients journeys:

Fighting Fire with Fire – Nicole’s Journey U Penn