June 29, 2008

LIFT cancer clinical trials

Human trials starting for Zheng Cui's LIFT 'cancer cure' H/T to Alfin

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.

The LIFT method and signing up for the trials The procedure was previously called GIFT.

LIFT is an investigational new cancer treatment that will transfer naturally-occurring cancer-killing activity (CKA) in the granulocytes of a selected donor into the body of a cancer patient.

Here's how the LIFT method works:

* Donor selection: Healthy young volunteers will be screened for the level of CKA, blood types, HLA types, infectious disease status, CMV status etc. by blood tests and physical examinations. The selected volunteers will become part of the Donor Registry. The test results of selected volunteers will be used to match with specific patients.

* Granulocyte collection: When a qualified patient is identified for treatment, granulocytes from several matched donors in the donor registry will be mobilized by two medications and collected by a well-established medical procedure called "apheresis" or "pheresis." A pheresis machine separates donor granulocytes from other blood products that will be immediately returned to donors so that the health impact on granulocyte donation is much smaller than on whole blood donation. Granulocyte mobilization and collection by apheresis have been used in clinical practices for a long time with very good safety record.

* Patient selection and granulocyte infusion: Qualified patients will be selected according to general health condition, disease status and match criteria. Freshly collected granulocytes from matched donors will be given to patients via IV infusion. Granulocytes cannot be stored or shipped for later uses.

Granulocyte infusion therapy has been traditionally used for treating neutropenia-related infections for over 30 years with excellent safety records. Since a significantly higher dose of granulocytes for each patient is proposed in our new cancer treatment, the primary goal of this clinical trial is to test whether the recipients can tolerate the proposed dose of granulocytes.

The main focus of the trial is the possibility of developing Transfusion-Associated Graft vs Host Diseases (TA-GVHD) and other potential side effects in the study subjects at higher doses of donor granulocyte.

Donor granulocytes per se are not known to produce TA-GVHD. However, granulocytes collected via apheresis may contain with some donor T-lymphocytes that in some rare occasions can produce various degrees of TA-GVHD in some individuals, especially the recipients with immune suppression. If possible, we will also make observations on the efficacy of this treatment on the study subjects with measurable diseases of cancer. We will recruit 22 cancer patients as study subjects for this trial.

More at redorbit


Tom Craver said...

It seems like a fairly obvious approach to try, if your goal is to cure cancer - look for mice who don't get or resist cancer, figure out at least superficially why they don't, and see if that factor can be transferred to others. It feels like something that should have been tried 30 or 40 years ago.

Am I missing something here, or have cancer scientists been too focused on "understanding" cancer, and not sufficiently focused on "curing it" - even as they use "the hunt for the cure" to draw huge public support and funding?

Frankly, I was angered by the line to the effect that "if he had been an immunologist, he would have thrown the mouse away". I think anyone who has lost someone to cancer would be, once they understand what that means. It's as if Flemming had said "Darn, that fungus is killing the staphylococci in my petri dishes - rats, it ruined my experiment."

Even in the article you link to, we get an example of a scientist saying "don't get too excited, they don't understand why it works". Shouldn't I get excited that - even if it doesn't work in humans - it could be closely examined to understand why it works in mice, and maybe transfer that understanding to a cancer cure for humans?

For years I've been wondering why we've had several generations of intensive cancer research, with relatively little result. Maybe it's because they've all had an attitude that is the perverse inverse of the old joke about the drunk looking for his keys "where the lights's better"?

I.e. it sounds as if they've refused to believe that there might be any solution that doesn't first require full understanding of how cancer works. "If it sounds too good to be true, we won't bother checking if it is, lest our collegues in science look down on us for our naivete."

bw said...

You are right that it is very exciting research. It is also something that should be worked on by more people. People working on figuring out the mechanisms and Cui working on the simple transfers.

For humans there could be more complications with the procedures but even with more typing and matching to prevent or limit rejection there is still high potential. Plus there was other work where a persons own immune system got boosted with a bunch of replicated cells. It seems a lot can be done with supercharging either our own immune system or transferring supercharged immune systems from others.

There is also a lot of lives to be saved with cheap and effective early stage detection.

vastiana said...

I would like to know what is the status of the study. Is it working so far? Please keep us informed about the course of this trial.
Thank you.

Marconi Brandão said...

I would like to know why the page is off the air and if the clinical test
already began.

regards, Marconi Jackson Silva Brandão.

bw said...

My understanding is that the clinical trials have been delayed into 2009. I think there is some kind of ethical review going on.

There is a private effort to apply the technique and also to save Chris Heward, who runs the Kronos Lab.

Go read about the private effort and sign up for it if you qualify.

bw said...

Kronos Lab LIFT trial effort

Please help us save the life of a valued member of the scientific community. All it takes is blood from a qualified donor.

You qualify if you:

- Live in Florida, driving distance to Boynton Beach
- Are 18-50 years of age
- Have an A+, A-, O+ or O- blood type. We can determine blood type with a simple blood collection if you do not know.
- Have never been diagnosed with cancer
- Have never been deferred from giving blood or blood products in the past (due to health)
- Have never had a blood transfusion
- Do not have an infectious disease
- Are not currently pregnant or breast feeding
- Have not had a multiple birth pregnancy (twins)
- Do not have a history of autoimmune disease, coronary artery disease, clotting in your arteries or veins, inflammation in your eyes, or sickle cell disease or one of its variants
- Do not have uncontrolled hypertension, diabetes, or active peptic ulcer disease

What is involved for the Donor?
- Pre-screening: Complete screening form via phone or e-mail to determine eligibility.
- Visit 1: Consent process and standard blood collection to determine donor/recipient match.
- Visit 2: Physical exam and standard blood collection for repeat testing.
- Visit 3: Preparation for granulocyte (white blood cell) collection.
- Visit 4: Granulocyte (white blood cell) collection (Apheresis—similar to plasma donation). See link below for additional information on the apheresis process.

There is nothing experimental about the blood collections or the apheresis procedure. Donors will be donating their blood, not receiving any blood products or experimental treatments. Visits will be conducted in Boynton Beach, FL.

Qualified donors will be reimbursed for their time and travel?

Visit Compensation Approximate Time Commitment
visit 1 $50 30 minutes
visit 2 $50 30 minutes
visit 3 $100 1 hour
visit 4 $350 3.5 hours

Daniel said...

"Ethical Review"...hate to say it, but it looks like big Pharma and/or the FDA is getting involved. If this approach were to work, look at the billions the cancer "research" infrastructure would stand to lose. This procedure needs to be tested---too many people have been lost. How do I donate to Kronos!

zotar said...

Please remove posts referencing the treatment of Chris Heward and Kronos. Chris passed away earlier this year.