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After a 20-plus-year battle with cancer and 12 brutal rounds of surgery and treatment, Stephanie Gangi was ready to give up.
When doctors found a new tumor the size of an grapefruit on her adrenal gland last summer, neither her mind nor body could take another course of chemotherapy.
To the shock of her two daughters and healthcare providers, the novelist, 66, declined further medical treatment. ‘I decided to see what happens; just take my chances,’ she told DailyMail.com.
‘My doctor, of course, hated that answer and so the next day called me and said there’s a clinical trial starting and I think it would be great for you.’
Ms Gangi was put on a last-resort trial in New York for patients whose cancers have spread around the body and become virtually incurable, known as ‘metastatic’.
She was one of 10 patients in the study, alongside William Morrison, 53, and Anna Bochenski, 51, who are either in partial or complete remission, despite being given just years to live.
They were given a vaccine developed at the famous Mount Sinai hospital in Manhattan, New York, that rapidly melts away the primary tumor and teaches the body to hunt and kill cancer cells that have spread elsewhere.
Stephanie Gangi, 66, (pictured left) had a tumor on her chest, and stopped wearing t-shirts as a result. ‘Being injected into that tumor was ‘pretty harrowing’, she said. William Morrison, 53, (pictured right) with his beloved dog after the clinical trial was over
Ms Gangi was given the injection directly into the large tumor that protruded from her sternum. The tumor had prevented her from wearing tops that showed her chest for years.
Within two months, the mass was completely flattened, and she celebrated being completely cancer-free at her daughter’s wedding earlier this year.
She said: ‘It’s hard to even wrap my head around it. I have had cancer for a very long time so it’s not just snap my fingers and have it not be present for me. I do get the same old “scanxiety” when I’m due for a test.’
‘I keep wondering, did it really work? Is it coming back? What’s happening? …But I feel great and I’m very grateful,’ Ms Gangi said. It is the first time in over ten years she has been medication-free.
Dr Thomas Marron — who is part of the team that have devoted the last decade to creating the vaccine — said ‘it was like winning the lottery’ when he saw the scan showing Ms Gangi’s adrenal tumor had gone.
He added: ‘That was the tumor that most likely would eventually have taken her life.’
People diagnosed with metastatic cancer often have very poor survival chances. With some cancers, the five-year survival rate is just six percent, according to the Mayo Clinic. The vaccine is injected directly into tumors, meaning only patients who have external cancerous masses can benefit currently. It contains a higher dose of a naturally occurring protein that rapidly multiplies levels of dendritic cells in the body – also known as ‘professor’ cells.
They kill the tumor that was injected, and teach T cells in the body to be on the lookout for more of the patient’s tumors. The new vaccine is among hundreds of experimental cancer vaccines and medicines currently in early trials.
The vaccine therapy has four components. Firstly four small doses of radiation over two days kill some of the tumor cells. This creates dead matter — an essential component for most vaccines. The patient is then injected with Flt3 ligand (Flt3L) to increase the number of ‘professor’ cells produced by the body, as well as a fake virus to switch on the ‘professor’ cells. They will destroy the tumor cells and teach the T cells what to be on the lookout for. The T cells will then look for other tumor cells in the body
Some utilize mRNA technology pioneered during the Covid pandemic and involve a unique shot that are entirely individualized and made from scratch for each patient. These can take months to make and cost around $100,000 per shot.
But the Mount Sinai candidate uses the same vaccine for each patient, meaning once doctors have perfected the shot, it can be rolled out to the mass market.
The chemicals involved are also cheap to make. Dr Brody said: ‘The ones we use cost pennies to dollars.’ Although technically a vaccine, the treatment in its current form is given in 17 doses and alongside eight immunotherapy injections.
Dr Brody and Dr Marron hope to reduce the number of shots giving to patients in the coming months.
Two other patients — Mr Morrison and Ms Bochenski — have also gone into complete and partial remission after receiving the experimental shot.
Mr Morrison, a clinical technician from New York, was diagnosed with blood cancer in 2017.
Things took a turn for the worst in 2018, when his cancer turned into a more aggressive type, and had spread to his groin and neck.
He had been enrolled in a trial in an earlier version of the Mount Sinai vaccine but did not respond. The father-of-two was put into remission briefly with chemo in 2019 but the cancer returned just as the pandemic hit.
Feeling ‘disheartened’ by the new diagnosis, he agreed to trial a new and improved version of the experimental shot in summer 2020 and within six months his tumors had completely cleared.
Mr Morrison has been in remission ever since, and said it felt like ‘the weight had been lifted from my shoulders’.
Ms Bochenski was struck with breast cancer in 2014, and embarked on rounds of chemo and surgery. In 2018, a tennis-ball-sized tumor appeared in her armpit, and the cancer had also spread to lymph nodes on her chest.
Her side effects from the cancer vaccine in January 2021 were intense, and left her ‘trembling to the point that I couldn’t hold a cup of tea’.
But the tumor under her arm disappeared and the treatment put her in partial remission.
Ms Bochenski said: ‘If I didn’t take the clinical trial, I would have been dead in 2021.’
The new vaccine is not for the faint-hearted. In total, patients receive 17 injections into the tumor and eight into their arm, as well as radiotherapy, over a total of six months.
Anna Bochenski, 51, (pictured left) after she had been through six months of fortnightly chemotherapy and a double mastectomy in November 2014. She is pictured on the right in 2012, two years before she was diagnosed with breast cancer
The therapy is split into four phases.
First, patients receive four small doses of radiation over two days to kill some of the cells in their cancerous tumor.
This creates dead matter in the tumor site.
Dr Marron told DailyMail.com: ‘You use that to create a vaccine that will hopefully teach your immune system to recognize and kill not only that tumor that you’re treating but also tumors elsewhere in the body.
‘If you think about the flu shot. The flu shot has two things in it. It has dead flu. This is basically the thing you’re trying to teach your immune system to recognize and kill. So it kills it right now but it also develops the memories that protect you from flu for the rest of your life.’
The treatment consists of administering a series of immune stimulants directly into one tumor site.
The first stimulant recruits important immune cells called dendritic cells that act like generals of the immune army.
The second stimulant activates the dendritic, or ‘professor’ cells, which then instruct T cells, the immune system’s soldiers, to kill cancer cells and spare non-cancer cells.
This immune army learns to recognize features of the tumor cells so it can seek them out and destroy them throughout the body, essentially turning the tumor into a cancer vaccine factory.
With the knowledge of how to spot and kill patient’s tumors, the T cells will travel around the body and destroy any other tumor cells they come across.
On day 23, patients start to receive the final component, pembrolizumab, given every three weeks for eight treatments.
This is an FDA-approved immunotherapy treatment, which takes the brakes off the body’s immune system and allows it to kill tumor cells.
Dr Brody said they are looking at ways of reducing the number of vaccines, so they could give one injection that would be the equivalent of nine.
Stephanie Gangi’s pre-vaccine scan (pictured left) showed a large tumor on her adrenal gland, which Dr Marron said would most likely have eventually ‘taken her life’. Ms Gangi’s post-treatment scan showed the tumor had completely melted away. Dr Marron said seeing the scan was ‘like winning the lottery’
Out of the ten patients enrolled on the trial, seven did not respond. But the vaccine is still in its early stages, meaning the doctors have time to perfect the shot and are still very pleased with the trial’s results so far.
The next step is to collate and examine all of the tests from all the responders to see if they can work out why it worked for some patients and not others.
As well as Mr Morrison, the doctors believe Ms Gangi may also be in complete remission, but cannot say for certain as her scan still has a small finding, which they think is just scar tissue.
Dr Marron said: ‘[Ms Gangi] had a huge tumor. The vaccine was administered to a tumor on her sternum, on her chest. The thing that we were worried about wasn’t this tumor that was growing out of her chest.
‘She didn’t like it, because it meant she couldn’t wear shirts that showed any of her chest.’
He added: ‘The thing that we were most worried about was that she had a tumor, the size of a grapefruit in her adrenal gland, right next to her stomach, and that is the tumor that most likely was very painful for her.
‘And that was the tumor that most likely would eventually have taken her life.’
After she received the vaccine treatment, he said: ‘By the time that we did the first PET scan, the tumor on the adrenal gland was completely gone.
‘To this day, she’s in remission, and she really doesn’t have any sites of active disease.’
But Dr Brody said his vaccine is ‘profoundly safer’ than other cancer therapies.
He told DailyMail.com: ‘There’s not too many cancer therapies we use that have a precedent of melting away large tumors and have almost no side effects.
He noted that the main side effect, a fever which lasts about a day, are ‘similar to the Covid vaccine’.
Dr Marron said: ‘Most patients will have received chemotherapy in the past, especially the breast cancer and the head and neck patients.
‘Chemo is much more toxic to the whole body but particularly to the immune system. Immunotherapy is like the opposite of chemotherapy in that chemotherapy really steps on your immune system and immunotherapy really revs up your immune system.’
Stephanie Gangi, 66, who was ‘ready to give up’ after 23-year cancer battle
Author Stephanie Gangi had tried 12 different types of treatment, but nothing would completely shift her cancer
In her mid-40s, Stephanie Gangi was diagnosed with breast cancer from a routine mammogram.
She cycled through 12 different treatments, undergoing surgery, radiation and chemotherapy. ‘I became the poster child for chronic illness,’ she told DailyMail.com.
These treatments put her into remission for ten years, but her cancer returned in 2011 and became metastatic, spreading to the bone and chest wall in 2014. She had a couple more rounds of chemotherapy.
In the summer of 2021, a tumor the size of a grapefruit appeared on her adrenal gland.
Ms Gangi said: ‘This time it was a little bit more distressing… This time it moved to my adrenal gland and that was the more distant metastases. It was on the move.’
In the middle of publicizing her latest book, her only option was another round of aggressive chemotherapy.
She said: ‘I thought it over and I talked to my kids and I said, I’m 66 and I’ve been dealing with this for so long and I’ve done every single thing successfully and it’s kept me going for 20-plus years.’
Ms Gangi decided not to do chemotherapy again and ‘see what happens, just take my chances, even for just six months’.
She was injected into a tumor on her sternum, where the most active cancer was.
She said: ‘I had a tumor that was starting to show on my chest, so much so that I would no longer wear a t-shirt. Maybe the average person didn’t notice it, but I noticed it.
‘[Getting injected into the tumor] was pretty harrowing, I’m not going to lie. But I did notice after about 90 days that the tumor had flattened. That’s when we knew I was having a positive response to the immunotherapy protocol.’
Ms Gangi celebrating after the vaccine trial ended on the weekend of her daughter’s wedding in Oakland, California
Ms Gangi said the side effects were ‘terrible’ and ‘I wanted to quit a million times’.
She said: ‘The fatigue was profound. A couple of days after treatment, I had classic flu-like symptoms, a fever, chills, complete body aches and zero motivation.’
But intense side effects were not all bad.
‘The suspicions were that the more robust the side effects, the better. That your body was really working to fight that. So I held on to that. And that has proved to be true,’ she said.
Ms Gangi at home with her dog in New York. She tried to keep things as normal as possible and continued working throughout her cancer treatment, but she said the fatigue from the vaccine therapy was ‘profound’
The trial therapies melted away Ms Gangi’s adrenal gland tumor and erased the cancer from the rest of her body. A small bump remains on her sternum, but doctors hope it is just a scar left behind from the cancer.
Despite her body’s positive reaction to the treatment, Ms Gangi said she does not feel completely cured.
‘But [the cancer] appears to be gone, which is amazing. It’s hard to even wrap my head around it.’
She added: ‘I have had cancer for a very long time so it’s not just snap my fingers and have it not be present for me. I do get the same old “scanxiety” when I’m due for a test.
‘I’m wondering, did it really work? Is it coming back? What’s happening? …But I feel great and I’m very grateful.’
For the first time in at least a decade, Ms Gangi does not have to take any drugs.
She said: ‘I have no pain so I’m not taking medication for it which is fabulous. I love not having to manage the medication.’
The treatment has meant she can enjoy her life even more: ‘I’ve been able to travel without worrying.
‘My kids are not worrying for the first time in years. It’s not constantly hovering over me.’
William Morrison, 53, suffered two devastating blood cancer diagnoses
William Morrison was diagnosed in 2017 with a type of blood cancer called follicular lymphoma.
As an initial form of treatment, he took part in Dr Brody’s first clinical trial, but it had little effect.
In early 2018, his cancer transformed into a more aggressive type of non-Hodgkin’s lymphoma.
Mr Morrison had six cycles of chemotherapy in the winter of 2018, which put him into remission for a year.
Just a year later, a scan showed the cancer had come back in a few spots, which he said was ‘disheartening’.
Mr Morrison prior to his cancer diagnosis (pictured left) and during chemotherapy treatment (pictured right)
Mr Morrison during the most recent clinical trial with his dog Luca
Mr Morrison in the summer of 2022 with his wife Lenore, son Brad, Brad’s wife Kelly, his younger son Billy and Billy’s girlfriend Ally
Mr Morrison told DailyMail.com: ‘That was a little disappointing because I thought it would have given me a few years or possibly more.’
He said: ‘That’s when [Dr Brody] mentioned this other, more recent clinical trial, which is similar to the first one that I had but they added some other types of medicine to it, they changed it a little bit.’
He started the second clinical trial in the summer of 2020 and finished it in January 2021, receiving injections in the neck area.
He suffered minor side-effects of flu-like symptoms such as body aches and a high fever.
The vaccine treatment cleared his cancer and he has been in complete remission ever since.
Mr Morrison said: ‘I was pretty relieved, like the weight had been lifted from my shoulders.’
He said: ‘I’m definitely glad that I decided to do it. I had some doubts initially, you hear from other people, “Do you think you should do it? It’s not a proven type of therapy. It’s experimental.” But my doctor told me I had nothing to lose.’
He added: ‘I’m happy that I pushed through it, and I would encourage anybody who’s in a similar situation to do it, because I’m two years out now in remission.’
Anna Bochenski, 51, was given only three years to live
Ms Bochenski said the vaccine therapy saved her life
Anna Bochenski was first diagnosed with breast cancer eight years ago at the age of 43.
She had surgery to remove a tumor in her right breast, but the cancer came back in a nearby spot just a couple of weeks later.
Ms Bochenski began fortnightly chemotherapy, followed by a double mastectomy.
In January 2015, she had radiation every day — a total of 32 sessions which left her cancer-free.
Three years later, she began to feel pain in her right ribs, and doctors discovered she had stage four terminal cancer in her ribs, spine and armpit — where she had a tumor the size of a tennis ball.
Doctors told her she had just three years to live. ‘It was pretty traumatic,’ she told DailyMail.com.
She said: ‘I went through every possible chemo. In December 2020 we learned that my cancer is not responding to any treatments, and this is it.’
In January 2021, she enrolled on the clinical trial and finally started seeing a positive change.
‘The tumor under my arm is completely gone,’ she said.
Her spine tumor has also cleared, and the one in her ribs has significantly shrunk. Most importantly, the cancer is not spreading.
With stage four terminal cancer, Ms Bochenski doesn’t think she will ever be able to stop taking a chemotherapy drug, but thanks to the clinical trial, ‘everything is under control’.
But her experience wasn’t completely smooth sailing and she was hit by side effects of the shot.
Ms Bochenski the day before her first chemotherapy in 2014 (pictured left). She chose to shave her head as she didn’t want to experience losing her hair. She is pictured right at Mount Sinai during the clinical trial on her first day of immunotherapy
She said: ‘The day I got injected… [later on] I was trembling to the point that I had such a shivery reaction, my hands were shaking. I could not hold a cup of tea or bottle of water.
‘I called Dr Marron and said I think I’m dying because I’ve never felt anything like this. My body went crazy. It lasted for two or three hours.
‘The shivering was so intense that I was worried that I was going to bite my tongue with my teeth. It freaked me out completely.
Ms Bochenski said the vaccine wiped her out for three days, after which she felt better and could return to work.
She said she would ‘absolutely’ recommend the treatment to a friend, adding: ‘If I didn’t take the clinical trial, I would have been dead in 2021.’