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Old 06-28-2008, 09:11 PM   #1
eric
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“Cure” in Mice to be Tested in Humans

http://www.newswise.com/articles/view/542007/?sc=rsmn
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 (Tswee), 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 http://www.cancer.org/docroot/ETO/co...cal_Trials.asp.)
For more information about qualifications for donors and participants, go to http://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. Gregory 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.


EDITORS: Additional resources – including still photos, SOT, B-roll, audio, Dr. Cui’s presentation abstract, and links to earlier news releases – are available at http://www.wfubmc.edu/news/CancerTrial.
Wake Forest University Baptist Medical Center (http://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.
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Old 07-01-2008, 09:24 PM   #2
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exciting news, hopefully it will be a success on human bodies, sometimes i look at those annoying little mice in the pet stores and feel really gratuitious that they exist. lol thanks for sharing eric
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Old 07-02-2008, 04:22 PM   #3
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This is awesome! I believe this is the first trial where they had a l00% success rate with the mice. The trial is taking place where I live and I am so excited. Yes! Those pesky little mice are good for something!
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Old 07-22-2008, 06:56 PM   #4
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This is exciting - I hope they have equal success in people.
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Old 07-22-2008, 08:47 PM   #5
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this is the trial called " LIFT " the one that I did apply for ..but so far no response yet !! last time I call them they told me that they finally got somebody interesting on the trial $$$ ...so maybe that is the reason for the delay ...I'm not sure about if insurance can or will not cover ...because is not drug involvement only blood and no even the whole blood only the leukocytes ...!!!!
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mastectomy right breast chemo before surgery herceptin/carboplatin/taxotere ,clear and surgery have radiation 20, `& then herceptin and tamoxifen
NED until Aug/07 body only then 'n June 04-06-07 .1 lesion of 1.6 cm on cerebellum ...novalis ,open sugery
5m.m brain met again novalis, 4mm.In the liver. Waiting 2 months now 3 tumors enroll on T-MCC trial start first infusion Nov 5/07 at Dec 17 scan show one tumor despair the 2nd and 3th diminish Doc said great results until March/08 ct scan show progression
03-05-08 start tykerb & xeloda
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Old 07-23-2008, 05:19 AM   #6
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Lily - my prayers are with you to get into this trial if that's what you want. Eric
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Old 07-26-2008, 02:36 PM   #7
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I hope you get in Lilly and it works as good for you (and everyone else) as it did for the mice! Good Luck, if I qualified I would try to get into this study myself.
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Old 08-01-2008, 02:56 PM   #8
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Lily,

I hope you receive good news about being accepted into this trial. The trial sounds very encouraging.

Amelia
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Old 08-09-2008, 12:50 PM   #9
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Dear freinds, they (Lift Trial researchers) said that we have to wait couples months before they can put all the things (burocratic papers etc) in orden to start this ..but they still recurring blood donor and potent patients ...so wait , they did send me a email saying all this ...I have faith on this trial ..I do .
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Lily
Diag April/06 5 months after give birth my son Max
stage IV mets on liver (5 tumors) 38 year old,
her2+++ and ER+PR+ from32 nodes 4 positives
mastectomy right breast chemo before surgery herceptin/carboplatin/taxotere ,clear and surgery have radiation 20, `& then herceptin and tamoxifen
NED until Aug/07 body only then 'n June 04-06-07 .1 lesion of 1.6 cm on cerebellum ...novalis ,open sugery
5m.m brain met again novalis, 4mm.In the liver. Waiting 2 months now 3 tumors enroll on T-MCC trial start first infusion Nov 5/07 at Dec 17 scan show one tumor despair the 2nd and 3th diminish Doc said great results until March/08 ct scan show progression
03-05-08 start tykerb & xeloda
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Old 09-08-2008, 05:48 PM   #10
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Yes..this is very cool. I wish I could donate...if my cells are worthy.
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Old 11-10-2008, 05:51 PM   #11
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Apparently recruiting donors:
http://nextbigfuture.com/2008/11/pri...leukocyte.html
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Old 12-11-2008, 06:21 PM   #12
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On insurance coverage : I thought that clinical trials were free for the patients..is this one not?
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Nov 2012 progressing on TDM1
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Dec 2012 Starting new trial S-222611 phase 1b dual egfr her2+ inhibitor.



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Last edited by fullofbeans; 12-11-2008 at 06:52 PM..
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Old 12-20-2008, 02:19 PM   #13
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Hmmm...LIFT website is down and the main doctor hasn't returned my e-mail...Aww..c'mon...thought they were recruiting donors.
????
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Old 12-20-2008, 07:04 PM   #14
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There is a good link that explains the ideas and ramifications:
http://www1.wfubmc.edu/tumorbio/srmouse/part1.htm
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Old 01-08-2009, 09:33 AM   #15
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Finally a response:

"currently on hold for institutional planning on how to move forward; recruitment temporarily suspended

hope to be ready to go in the spring if all goes well"
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Old 01-08-2009, 03:52 PM   #16
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Thanks for the update Rich.
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Old 04-17-2009, 10:51 AM   #17
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Aaarrrg!
Since spring has sprung, I asked for an update....

"on hold indefinitely; challenges deciding how to fund clinical trial"

With all the money flying around in bailouts and research of far less potential benefit....
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Old 04-17-2009, 07:08 PM   #18
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Incredibly frustrating! Anyone know what % of lab tests show this kind of success that would explain the funding problem?
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Old 04-24-2011, 10:44 PM   #19
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Re: “Cure” in Mice to be Tested in Humans

bump. anyone who received an update? is there a way for us to unite and help to find (financial) donors for these types of trials?
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Old 04-25-2011, 09:58 AM   #20
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Re: “Cure” in Mice to be Tested in Humans

A more updated thread here:
http://her2support.org/vbulletin/sho...ocyte+infusion

Last time I communicated with them, they were in a catch 22 of needing more funding to treat patients ($100k/each) and needing more patients to get funding. I'll check in to see what's up.
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