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Alert Number 107

An Interesting Vaccine Trial for CLL Patients

Date: July 17, 2005

I have to admit, I do a slow burn every time I read about vaccine trials for NHL patients, CLL patients excluded each and every time. Well, for a change, I am happy to report there is a customized, patient-specific vaccine trial about to start in the next couple of months. The vaccine will be custom made, based on blood samples obtained from each patient.

I have been corresponding with Dr. David Spaner (Division of Molecular and Cellular Biology, Research Institute, Sunnybrook and Women's College Health Sciences Center, Toronto) for more than a couple of years. The results of his Phase-I clinical trial are reported below: 11 out of the 18 patients who participated in this trial had partial response or stable disease. Not bad at all, given there was minimal toxicity! A significantly improved version of this approach (with the addition of an interesting adjuvant to kick-start the vaccine) is about to be announced this summer. I will be reporting the full details of the new clinical trial as soon as I am at liberty to do so, possibly in the next couple of weeks. Keep an eye out for it. For now I want to say I am pretty impressed by the approach. It promises to be a low toxicity, low pain approach, and for patients in Watch & Wait it provides an attractive option to consider. It may be just enough to keep your CLL at a low simmer rather than galloping off to more dangerous levels, and the price tag is right in terms of very low toxicity. What is not to like?

The fly in the ointment is that the trial is going to be held in Toronto, and there are all sorts of serious insurance and liability reasons why it may not be open to patients in the United States. I am working with Dr. Spaner to see if we can find a way around this little roadblock. Even if we do not succeed in opening the trial to U.S. patients this time around, the technology is worth watching and worth supporting. If this Phase-II trial shows good promise, it is a safe bet it will be picked up promptly by one of our U.S. research centers.

Our "Project Alpha" EGCG (green tea extract) clinical trial announcement for patient recruitment at the Mayo Clinic is going to be made before the end of this month. In the next week we will be sending Mayo our check for the money we promised as funding for the EGCG trial. With that trial under way, it is time for us to think about new approaches that we wish to support. Dr. Spanerís vaccine approach sounds good enough that I think we should support it with a little seed money, just enough to help kick start it. We are a small non-profit volunteer group, we do not have the people or financial muscle to give big bucks. But if we can win friends and influence people with small donations, enough to get them interested in looking seriously at therapy options for CLL patients, I think that is a savvy thing to do. It is a whole lot better than sitting back and waiting for some one to notice us, include CLL in their high priority research projects.

For all the generous contributors to our Project Alpha fund, a sincere "thank you". If encouraging the vaccine trial sounds good to you, send in your hard earned dollars. For details, see: Donations. We do not have a lot of time for fund-raising on this one, since Dr. Spaner is eager and able to get moving on this in the next few months. I hate to sound like Public Television stations during pledge weeks, but this is your gig, your life, your therapy options down the road we are talking about. I cannot tell you how important it is to have a seat at the table as decisions are being made. We might be able to make a difference here with a relatively small amount of cash, hopefully we can raise that quickly, within the next month or so.

Be well,

Chaya
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Abstract

Cancer Immunol Immunother. 2005 Jul;54(7):635-46.

A phase I/II trial of oxidized autologous tumor vaccines during the "watch and wait" phase of chronic lymphocytic leukemia.

Spaner DE, Hammond C, Mena J, Foden C, Deabreu A.

Division of Molecular and Cellular Biology, Research Institute, Sunnybrook and Women's College Health Sciences Center, Toronto, ON, Canada

Based on their activity in patients with advanced stage chronic lymphocytic leukemia (CLL), a phase I/II study was designed to evaluate the feasibility, safety, and efficacy of autologous vaccines made from oxidized tumor cells in patients with earlier stage CLL, and to determine an optimal schedule of injections. Eighteen patients (at risk for disease progression and with white blood cell counts between 15 and 100 x 10(6) cells/ml) were injected intramuscularly with 10 ml of oxidized autologous blood (composed mainly of CLL cells) either 12 times over 6 weeks (group 1), 12 times over 16 days (group 2), or 4 times over 6 weeks (group 3). Fourteen out of eighteen patients had Rai stage 0-II disease, while 4/18 had stage III-IV disease but did not require conventional treatment. Partial clinical responses, associated with enhanced anti-tumor T cell activity in vitro, were observed in 5/18 patients of whom three were in group 2. Stable disease was observed in six patients while disease progression appeared not to be affected in the remaining patients. Toxicity was minimal. Vaccination with oxidized autologous tumor cells appears worthy of further investigation and may be a potential alternative to a "watch and wait" strategy for selected CLL patients.

PMID: 15918075
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