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Wake Forest University Baptist Medical Center

Cancer 'cure' in mice to be tested in humans

WINSTON-SALEM, N.C. †" 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.

###

Yikong Keung, M.D., a medical oncologist, is the chief clinical

investigator of the study. Pomper, M.D., assistant professor

of pathology and the director of the Wake Forest Baptist blood bank,

will oversee the blood banking portion of the study.

Media Contacts: Jonnie Rohrer, jrohrer@..., (336) 716-6972,

Guenzel, jguenzel@..., (336) 716-3487, or Bonnie ,

bdavis@..., (336) 716-4977.

EDITORS: Additional resources †" including still photos, SOT, B-roll,

audio, Dr. Cui's presentation abstract, and links to earlier news

releases †" are available at www.wfubmc.edu/news/CancerTrial.

Wake Forest University Baptist Medical Center (www.wfubmc.edu) is an

academic health system comprised of North Carolina Baptist Hospital ,

Brenner Children's Hospital, Wake Forest University Physicians, and

Wake Forest University Health Sciences, which operates the

university's School of Medicine and Piedmont Triad Research Park . The

system comprises 1,154 acute care, rehabilitation and long-term care

beds and has been ranked as one of " America 's Best Hospitals " by

U.S. News & World Report since 1993. Wake Forest Baptist is ranked

32nd in the nation by America 's Top Doctors for the number of its

doctors considered best by their peers. The institution ranks in the

top third in funding by the National Institutes of Health and fourth

in the Southeast in revenues from its licensed intellectual property.