Scientists at Wake Forest University Baptist Medical Center are
about to embark on a human trial to test whether a new cancer treatment
will be as effective at eradicating cancer in humans as it has proven
to be in mice.
The treatment will involve transfusing
specific white blood cells, called granulocytes, from select donors,
into patients with advanced forms of cancer. A similar treatment using
white blood cells from cancer-resistant mice has previously been highly
successful, curing 100 percent of lab mice afflicted with advanced
malignancies.
Zheng Cui, Ph.D., lead researcher and
associate professor of pathology, will be announcing the study June 28
at the Understanding Aging conference in Los Angeles.
The
study, given the go-ahead by the U.S. Food and Drug Administration,
will involve treating human cancer patients with white blood cells from
healthy young people whose immune systems produce cells with high
levels of cancer-fighting activity.
The basis of the study
is the scientists’ discovery, published five years ago, of a
cancer-resistant mouse and their subsequent finding that white blood
cells from that mouse and its offspring cured advanced cancers in
ordinary laboratory mice. They have since identified similar
cancer-killing activity in the white blood cells of some healthy humans.
"In
mice, we’ve been able to eradicate even highly aggressive forms of
malignancy with extremely large tumors," Cui said. "Hopefully, we will
see the same results in humans. Our laboratory studies indicate that
this cancer-fighting ability is even stronger in healthy humans."
The
team has tested human cancer-fighting cells from healthy donors against
human cervical, prostate and breast cancer cells in the laboratory –
with surprisingly good results. The scientists say the anti-tumor
response primarily involves granulocytes of the innate immune system, a
system known for fighting off infections.
Granulocytes are
the most abundant type of white blood cells and can account for as much
as 60 percent of total circulating white blood cells in healthy humans.
Donors can give granulocytes specifically without losing other
components of blood through a process called apheresis that separates
granulocytes and returns other blood components back to donors.
In
a small study of human volunteers, the scientists found that
cancer-killing activity in the granulocytes was highest in people under
age 50. They also found that this activity can be lowered by factors
such as winter or emotional stress. They said the key to the success
for the new therapy is to transfuse sufficient granulocytes from
healthy donors while their cancer-killing activities are at their peak
level.
For the upcoming study, the researchers are currently
recruiting 500 local potential donors who are 50 years old or younger
and in good health to have their blood tested. Of those, 100 volunteers
with high cancer-killing activity will be asked to donate white blood
cells for the study. Cell recipients will include 22 cancer patients
who have solid tumors that either didn’t respond originally, or no
longer respond, to conventional therapies. The study will cost $100,000
per patient receiving therapy, and for many patients (those living in
22 states, including North Carolina) the costs may be covered by their
insurance company. There is no cost to donate blood. For general
information about insurance coverage of clinical trials, go to the
American Cancer Society’s web site at www.cancer.org/docroot/ETO/content/ETO_6_2x_State_Laws_Regarding_Clinical_Trials.asp.)
For more information about qualifications for donors and participants, go to www.wfubmc.edu/LIFT
(Web site will be available the evening of 6/27.) Cancer-killing
ability in these cells is highest during the summer, so researchers are
hoping to find volunteers who can afford the therapy quickly.
"If the study is effective, it would be another arrow in the quiver of
treatments aimed at cancer," said Mark Willingham, M.D., a
co-researcher and professor of pathology. "It is based on 10 years of
work since the cancer-resistant mouse was first discovered."
Volunteers
who are selected as donors – based on the observed potential
cancer-fighting activity of their white cells – will complete the
apheresis, a two- to three-hour process similar to platelet donation,
to collect their granulocytes. The cancer patients will then receive
the granulocytes through a transfusion – a safe process that has been
used for more than 30 years. Normally, the treatment is used for
patients who have antibiotic-resistant infectious diseases. The
treatment will be given for three to four consecutive days on an
outpatient basis. Up to three donors may be necessary to collect enough
blood product for one study participant.
"The difference
between our study and the traditional white cell therapy is that we’re
selecting the healthy donors based on the cancer-killing ability of
their white blood cells," said Cui. The scientists are calling the
therapy Leukocyte InFusion Therapy (LIFT).
The goal of the
phase II study is to determine whether patients can tolerate a
sufficient amount of transfused granulocytes for the treatment.
Participants will be monitored on a regular basis, and after three
months scientists will evaluate whether the treatment results in clear
clinical benefits for the patients. If this phase of the study is
successful, scientists will expand the study to determine if the
treatment is best suited to certain types of cancer.




Recent Comments