As Darby Steadman steps out of her champagne Volvo station wagon, the valet parking attendants at the Johns Hopkins garage warmly welcome one of their regulars. She'll make the 30-minute trip from her Severna Park home every day this week and more than a dozen times this month.
In Baltimore, she will endure a half-dozen blood draws, a dose of chemotherapy, a dose of another intravenous drug, 12 shots of an experimental breast cancer vaccine, two skin biopsies, and three other vinegar-like injections that are so excruciating that patients say numbing cream does nothing. All of this comes over the next eight days in July, a carefully scripted routine of the breast cancer vaccine trial she has been enrolled in since April.
She knows the schedule by heart. This is her third time through and - should her advanced breast cancer stay in check - she will be back again in October, when the valets will greet her all over again.
It's a part-time job with an uncertain payoff.
Enrolling in one of Dr. Leisha Emens' vaccine trials is a far cry from getting a tetanus shot. It is a long-term commitment for a group of women with terminal cancer - 42 so far - who are otherwise making few long-term plans. They are the "almost dead," as one of the women puts it.
On four occasions over the course of six months, women like Steadman scramble to find friends to watch their children after school and cook a week's worth of meals so they can rest - or in the case of those who come from out of state, find a place to stay and a way to pay for it. Then there are the additional blood tests and medication required during off weeks, the regular bone and CT scans given to track progress, and the extra visits sometimes necessitated by unforeseen complications. They are paid nothing for this investment of time, save coupons for free parking, and must cover some of the insurance co-payments themselves.
The trade-off is a chance, slim as it may be for these pioneers, at making it longer than the one to two years that women with Stage IV cancer typically survive.
Emens believes she can train the body's immune system to attack cancer cells. For now it is an experimental treatment for the sickest of patients. Though it is a long shot, the research she is doing may lay the groundwork for a vaccine that could one day prevent breast cancer, which kills more than 40,000 U.S. women each year.
This is how new medicines are made. The vaccine has done wonders in some mice, leaving them cancer-free. Though by many accounts a promising therapy, it remains unknown whether the vaccine will prolong the lives of people, particularly the women with terminal breast cancer enrolled in Emens' early trials.
Cancer intrudesDarby Steadman, 38, lives a fairly typical suburban life - married to the high school sweetheart she met on the homecoming court in Tampa, Fla., channeling the energy she once used in her career as a television executive into overseeing the busy schedules of 9-year-old Liam and 6-year-old Audrey, organizing games of Bunco and cookouts with neighbors, going to church on Sundays. Cancer, though, keeps interfering.
In 2004, she was diagnosed with ductal carcinoma in situ, a noninvasive cancer considered unlikely to spread. Her mother had been diagnosed with breast cancer a decade earlier, so Steadman made a radical choice. She had both breasts removed, even though the cancer was in only one. By choosing this surgery, she was told, the risk that the cancer would come back was less than 1 percent.
But the cancer returned last fall. It showed up in her lymph nodes and the vertabrae in her neck. She could tell right away that something was wrong, but she hadn't lived in Maryland long and didn't have an oncologist. When she finally found a doctor, she could read the bad news in the pity betrayed by the woman's eyes.
But then life got in the way of the mourning. "There's not a lot you can do," she says. "The kids still have to be fed, and the laundry still needs to be done."
In April, on her daughter's sixth birthday, Steadman got her first vaccine. Three months later, she has returned for her third round. In the intervening weeks, she has felt the cancer in her lymph nodes shrinking to the touch, the cancer in her spine causing less pain. She arrived at Hopkins upbeat on this July morning, despite the physical rigors she knew vaccine week would bring.
On Monday, she gets a low dose of cyclophosphamide, a chemotherapy agent. It is just enough to go after something called regulatory T-cells, which suppress the immune system. Removing the influence of regulatory T-cells should in turn allow the vaccine to stimulate the body's killer T-cells. Killer T-cells are a type of white blood cell that play a large role in the immune system, identifying, attacking and destroying the unfamiliar.
Vaccination dayTuesday is vaccination day and on this morning, Steadman is like an excited kid watching a science experiment. Her attitude seems out of sync with the gravity of the situation, but for Steadman a positive mind-set and a sense of humor are the only ways she can fend off the reality of metastatic cancer.
At 10:42, research nurse Silvia Petrik calls the lab to alert them that Steadman is ready. Steadman spends some of the downtime talking about her two children, about the friends who have made meals, baby-sat her kids and kept her company on her many visits to Hopkins. Petrik, meanwhile, dabs numbing cream on the spots where she will insert the needles.
Thirty minutes later, a technician in scrubs arrives carrying a gray cooler. Inside is a baggie filled with ice chips - and 12 slender syringes, containing the vaccine of irradiated cancer cells modified to secrete a protein that signals danger. With the vaccine cells sending up a red flag, the stage should be set for her immune system to recognize them - and any breast tumor - as foreign attackers to be stopped. Emens hopes this will stimulate Steadman's body to naturally fight cancer.
The first shot goes slowly into Steadman's back, its clear liquid pooling just under the skin. When the needle is removed, the spot where it went in is now marked by a drop of blood. This goes on injection after injection - four in her back, four in each thigh. Sometimes Steadman keeps her eyes closed. Sometimes she winces.
Before long, Petrik can feel heat rising from each shot site. Soon there are blisters.
By the afternoon, Steadman's legs would be red, with the bumps growing into large welts. By Wednesday, they would meld into big blobs. By Thursday, the welts would start to disappear, leaving in their place ugly, yellowing bruises. None of this alarms her anymore. This is the third time she's been through the drill.
On Day Eight - a week after the vaccination - Steadman is back to see Petrik. What remains of the shots a week earlier feel like pebbles under the skin.
Petrik measures each vaccine site, then biopsies the largest one to determine what kind of immune system cells have been drawn there.
Steadman just needs an intravenous dose of the breast cancer drug Herceptin, a requirement in her trial, before she can leave Hopkins for two weeks. But the next morning she wakes up with angry hives all over her body and races back to the hospital for mega doses of Benadryl.
What seems like an unfortunate side effect may in fact be a good omen. Emens and Petrik excitedly come to see her. They have heard of patients in other vaccine studies getting serious hives - showing the body is having a clear immune response - but not in the breast cancer trials. Petrik even takes digital photographs of Steadman's buttocks for possible publication in a medical journal.
Steadman laughs her raspy laugh. As long as they think this means the vaccine is working, she's up for anything. And while they don't know for sure, neither the doctor nor the nurse has any other explanation.
Steadman thinks of her 6-year-old daughter as she endures the demands of the trial. Audrey could be more likely to get breast cancer herself because of the family history. If Audrey could get a preventive vaccine, one that her mother played a tiny role in developing, "wouldn't that be wonderful?"
Dinner for fourNo matter what, no matter how she is feeling, all four Steadmans try to have dinner together every night. One recent evening, grilled vegetables and homemade pizzas were on the menu. Liam cut white and purple eggplants under his mother's watchful eye, while Audrey drizzled the slices with balsamic vinegar. Each child helped stretch the pizza dough into ovals ready for topping.
Around the dinner table, Steadman learns what is really on her kids' minds. Sometimes, it's cancer. Her diagnosis isn't much of a secret in their close-knit neighborhood. "This is my mom," Audrey has been known to say by way of introduction. "She has cancie."
Sometimes, what is discussed at other dinner tables comes back to theirs.
One night, "Audrey said, 'Mikey told me you're dying of cancer,'" Steadman recalled. "I said, 'Yes, cancer makes you sick, sometimes it can make you really sick and sometimes people do die from cancer.' It was actually a wonderful moment." Steadman took the opportunity to talk about life and about heaven and to reassure them, "God's not done with me yet."
At bedtime, Liam and Audrey huddle with their mother to say their prayers. They put their hands on her neck, touching the spot where her cancer lives, as if trying to heal her.
In early August, three weeks after the hives appeared, Steadman and her husband, John, return to Hopkins for an appointment with Emens. They are anxious, knowing the doctor's words could again send their lives into a tailspin, but they are optimistic.
Emens' answer: "Everything looks good."
She sends them off until late October when Steadman is scheduled for her fourth round of vaccine.
On the way out the door, Steadman and Emens talk about the oncologist's recent trip to the summit of Mount Kilimanjaro. Steadman has never been on a climb. But she tells Emens that if she is feeling up to it - and she expects to feel up to it - she wants to scale Mount Cotopaxi in Ecuador, the January destination for a group that has raised more than $300,000 for Emens' research.
"By January I'll be good," she assures Emens.
"We can keep hoping," her husband says.
more on the series Coming tomorrow in The Baltimore Sun:
A group of women in the vaccine trial refuse to just be anonymous test subjects. Instead, they have found one another on the sly and depend on each other not only for moral support but for clues about whether the vaccine works.
Online at baltimoresun.com/vaccine: Watch a video of Darby Steadman discussing her experiences with the vaccine trial and find more photos, videos and previous installments of the series.Copyright © 2014, The Baltimore Sun