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“PANCVAX” CLINICAL TRIAL IS
FIRST STUDY OF DENDRITIC
CELL VACCINE IN PANCREATIC
CANCER PATIENTS
AT BAYLOR UNIVERSITY MEDICAL CENTER AT DALLAS
Patients receive a combination of chemotherapy and cancer vaccine in an effort to spur
their immune system into fighting the cancer
“We’re trying to innovate. We’re trying to push
the field forward. We’re trying to do something
for this cancer that has such a great unmet
medical need,” she said. “That’s the beauty of an immunotherapy. If you
can get the immune system stimulated against
the cancer, it will just kill it, regardless of how
many mutations there are.”
The first of these women on the study, “Safety
study of chemotherapy combined with dendritic
cell vaccine to treat breast cancer,” was dosed
in December 2013. Since then, two have died
from disease recurrence. “The other eight
remain without any detectable disease,” Dr.
O’Shaughnessy said. Still, she is not ready to talk about this clinical
trial as promising just yet. She had hoped that
more of the women in the study would have
registered a pathological complete response
(PCR), meaning no cancer in their breast
or lymph nodes, prior to surgery. As it was,
approximately half recorded a PCR, about the
same as standard chemotherapy.
“These patients all had very high risk of dying
from triple-negative breast cancer without
effective therapy,” she said. “The whole idea is
to wake up these dendritic cells, which basically
are not functioning. Their immune system was
not working to kill off this cancer.”
Genomic-driven targeted therapies can also
help TNBC patients, but these cancers are often
driven by multiple mutations. What if there are
other mutations ready to step to the plate and
take over? “When we think about targeted
therapies, we think about a drug targeted
against one mutation or one driving [cellular]
pathway in the cancer,” Dr. O’Shaughnessy said.
One outstanding question is whether the
dendritic cell therapy activated the immune
system and either held off or eradicated any
residual microscopic disease. As she waits
to see if the eight women in the study will
remain free of cancer for at least three years,
Dr. O’Shaughnessy is hopeful that the vaccine
will continue to act as a maintenance drug.
This study was funded by the Amy T. Selkirk Fund for
Breast Cancer Immunotherapy, part of Baylor Health
Care System Foundation.
This year, pancreatic cancer will eclipse breast cancer to become the nation’s third-
leading cause of cancer-related death. Patients with lung, colorectal and breast
cancer—the other leading causes of cancer mortality—all have benefited from
new treatments, leaving the number who die from these cancers relatively stable
over the past five years. But the number of patients who die of pancreatic cancer
has increased more than 10 percent during that same period, and the disease
now accounts for nearly 42,000 deaths annually. Most die within the first year of
diagnosis, with fewer than 10 percent surviving more than five years.
Carlos Becerra, MD, medical director of Baylor University Medical Center’s Innovative Clinical Trials Center
and interim deputy chief of oncology for Baylor University Medical Center at Dallas, said that clearly new
treatments are needed for this most aggressive of cancers.
The high mortality rate in pancreatic cancer is due largely to the lack of method for early detection; most
patients have advanced disease by the time they are diagnosed. One avenue of hope is a Baylor University
Medical Center at Dallas clinical trial, which for the first time uses a dendritic cell vaccine in an effort to
mobilize the patient’s own immune system to combat pancreatic cancer.
The study, “Dendritic cell vaccine and chemotherapy for patients with pancreatic cancer,” or PancVax, is a
single center exploratory safety trial that is evaluating the effectiveness and safety of combining a cancer
vaccine with chemotherapy, including the standard-of-care treatments of FOLFIRINOX or the combination
of gemcitabine plus nab-paclitaxel.
“We want to determine if we can elicit an immune response,” said Dr. Becerra, whose study is based on a
storied history at Baylor University Medical Center at Dallas. It was prompted by the early efforts of staff at
the Baylor Institute of Immunology Research (BIIR); they used dendritic cell therapy to lengthen the survival
of Dr. Ralph Steinman, who developed pancreatic cancer. He was the Nobel Prize laureate who discovered
the dendritic cell and its role in adaptive immunity. In addition, the world’s first cancer vaccine against
melanoma was pioneered at BIIR.