After an otherwise-healthy and vibrant 24-year old newlywed was diagnosed with an aggressive brain tumor and given just two-to-three years to live, a new clinical trial – based on NBTS-funded research – provided hope and helped beat the odds
“Temozolomide is what it is: a chemotherapy,” says Greg. “This means constantly feeling drained of your energy and throwing up if you didn’t take your anti-nausea medicine. This was my life for six months.”
Greg was diagnosed with a Grade III anaplastic astrocytoma – part of an aggressive class of brain tumors known as high-grade gliomas, which also include glioblastoma – in February of 2013, when he was just 24-years old. At the time, he was working a full-time job in sales for a major corporation and happily settling into married life. As Greg tells it, he was living the dream with his new bride of six-months and a puppy they had just adopted.
Then a seizure in his sleep one night threatened to change all of that.
Taken to the ER and for an MRI, the erstwhile healthy young man was told that he had a brain tumor. Surgery to remove the tumor and the accompanying pathology report would provide the diagnosis of a highly malignant and aggressive brain cancer.
“My first oncologist gave me a prognosis of two-to-three-years to live,” says Greg. “I quickly told her, ‘You cannot put a timestamp on my life. Only God can do that!’ Then I asked: ‘What’s your plan for treatment?’”
His initial treatment would be what virtually all other high-grade glioma patients receive: radiation and temozolomide. (Note: many doctors now also consider the addition of the device Optune following its approval by the FDA in 2015.)
The addition of temozolomide to radiation treatment following surgery became the “standard-of-care” for most adults with malignant brain tumors in 2005, but the chemotherapy was originally approved to treat anaplastic astrocytomas in 1999. Its advent increased average survival time for the worst brain tumors by three months, from nine to 12, and for some, significantly longer. Temozolomide was a step forward, albeit a small one, for brain tumor patients. But it was 12-18 years ago now. And, as Greg notes, it’s not a particularly pleasant therapy, as no chemotherapies are.
As such, NBTS is constantly funding research and other efforts to accelerate the pace of development for new therapies that will hopefully not only improve survival, but also prove less-toxic and harsh on patients.
One such potential new treatment is an experimental therapy, called Toca 511 & Toca FC, developed by a company called Tocagen. NBTS provided an “Innovation Grant” to Tocagen to help develop this treatment approach.
In 2016, Tocagen reported initial results from trials evaluating the use of Toca 511 & Toca FC as a potential treatment for high-grade glioma patients. In three separate, but related, studies, preliminary data was encouraging and warranted moving forward with further trials.
Greg is one of the early patients who tried the Toca 511 & Toca FC treatment by enrolling in one of its clinical trials. And this NBTS-funded treatment is perhaps to credit for why Greg has not only survived past his initial two-to-three-year prognosis, but is thriving.
“[My] life today is wonderful,” says Greg. “My wife and I had a baby last year, Colton, who is now a year-and-a-half and is walking and talking. Seeing him grow-up is beyond words – a dream we didn’t think would happen is happening.”
Greg’s new path began when he transferred treatment centers to Henry Ford Hospital in October of 2013. It was there that his new medical team discussed with him additional options for his treatment, including clinical trials.
“My neurosurgeon told me only about 4% of cancer patients will attempt a trial,” says Greg. “I decided that even if it doesn’t work for me that maybe it will work for someone else. After being given a death sentence at such a young age, I was determined to fight and find a treatment that was right for me. We signed up for the [Tocagen] trial and under the knife I went for the second time in six months.”
Toca 511 & Toca FC are, in fact, two separate substances designed to be used together to selectively kill cancer cells and activate the immune system against tumors — as opposed to chemotherapy like temozolomide, which primarily works by indiscriminately killing dividing cells.
“I had a good experience on the trial, and didn’t experience many side-effects,” says Greg. He additionally notes that he found the treatment regime to be relatively easy to follow.
“I’m happy to say that overall, today, life is pretty normal.”
In early 2017, Toca 511 & Toca FC was granted “Breakthrough Therapy Designation” by the U.S. Food and Drug Administration (FDA), meaning Tocagen will receive the highest level of FDA attention as they continue to develop and evaluate this treatment approach. This does not guarantee that Toca 511 & Toca FC will ultimately be approved for all high-grade glioma patients – that still has to be determined through further clinical trial evaluation and final review and approval by the FDA – but it is an important step that will expedite the development of this potential new treatment. (In an update just a couple short weeks ago, Tocagen announced that, based on their communications with the FDA under Breakthrough Therapy Designation, Tocagen will immediately accelerate Toca 511 & Toca FC clinical development by modifying the original two-step trial design [Phase 2 followed by a Phase 3] into a seamless, pivotal trial, known as the Toca 5 trial.)
In the meantime, Greg goes on with his life as anyone else would. “I plan to watch my son grow and go to school, one day get married and have kids of his own,” he says.
And he says he’ll always look back appreciatively and positively on his decision to enroll in the Toca 511 & Toca FC trial.
“We need research and trials like Tocagen’s, and organizations like NBTS willing to fund it, in order to make progress,” says Greg, adding later, “Take a step back and just think, what would you do if you were faced with a decision to potentially help the world find a cure for cancer?”
Toca 511 & Toca FC are currently being evaluated in multiple clinical trials for high-grade glioma patients and additional data are expected in 2018.
“You are not a number,” Greg concludes. “Nobody can tell you what your life expectancy is…fight, fight, fight.”
Please help support NBTS in its quest to fund potentially life-saving research by making a gift today.
NBTS has provided funding to help with the research and development of Toca 511 & Toca FC. NBTS is hopeful that the clinical trials of Toca 511 and Toca FC will succeed and provide a new treatment option for certain glioma patients, as we do for all drug candidates currently in trials for different brain tumor types. As with all clinical trials, NBTS cannot provide recommendations on which trial(s) brain tumor patients should consider. We advise all brain tumor patients to discuss all their treatment options, including all potential clinical trials available, with their medical team.