Immune T-cell treatment study in Detroit for NEW stage 2 or 3

I just wanted to let everyone know about a cool new immune system treatment clinical trial that has come out. I am participating in the version for metastatic patients, but there is also a version for newly diagnosed stage 2 and 3 patients with medium sized and larger tumors (2 cm and larger). It is only being done at Karmanos Cancer Institute in Detroit, MI, so you would need to live near or travel there in order to participate.

You have to be HER2 negative. I think the info below says triple negative, but Dr. Lum says they have changed that to any hormonal status. You DO have to be newly diagnosed, biopsy ONLY, and able to take neoadjuvant treatment (chemo before surgery and/or radiation).

They are having trouble recruiting patients for the study because not that many people get neoadjuvant chemo, though it is considered as effective as chemo done after surgery. Plus, if you get a lumpectomy, you might get better looking surgical results if the chemo and immune system treatment shrink the tumor before surgery.

The timeline is that after your are diagnosed with a biopsy, you sign-up in person in Detroit for the trial. Then they do a "pheresis" where they take out some of your T-cells from your blood, and put the rest of your blood back. T-cells are a part of your immune system that helps you to fight cancer. The idea is to make them stronger to help you to fight the cancer better, after your chemo is completed.

You get the standard TAC (Taxol, Adriamycin and Cytoxan) treatment wherever is convenient to you, either in Detroit or at your local oncologist's office or hospital. In the mean time, the laboratory people go do their magic of taking your T-cells and changing them into armed, activated T-cells. When you are done with the TAC, you go back to Karmanos for four weekly infusions of your new, hopefully improved T-cells. Finally, you get your surgery with or without radiation (depending on your doctor's recommendations), AFTER the chemo and T-cell immunotherapy.

It is possible to travel to participate in this study. I've traveled (flown) about 1,000 miles each way from the southern Midwest to Detroit four times now, with a 5th visit planned for a booster in December. It hasn't been easy, but it's not impossible either. Whether or not you travel, you WILL need an adult treatment buddy to drive you to Karmanos, be with you most of the day, and take you home and look after you overnight. You must stay within a 30 minute drive of the Detroit Medical Center, even overnight, in case of a serious side effect.

The actual treatment itself is hard the day of, but within 24 hrs you are mostly back to normal. I think mine was a little harder than most, because I'm allergic to Demerol which they typically give to help dampen the flu-like reaction (fever, low blood pressure, shaking chills, sometimes nausea/vomiting). The first T-cell treatment is the hardest, which is just the opposite of how chemo works in my experience.

This study is very cool scientifically, because the researchers can go in and look at any left-over tumor to see what kind of immune system response the patient has to the T-cell infusions, especially in killing tumor stem cells. So, they get timely feedback on potential effectiveness, instead of having to wait years to see if patients have any recurrences. It is a phase 2 study, which means that safety has been established, but not effectiveness.

If you know someone who is newly diagnosed (biopsy only) and HER2 negative who would be interested in this trial, please let them know about this.

Here is info from Karmanos web site:

http://www.karmanos.org/view_news.asp?id=779

and the technical information from clinicaltrials.gov

http://clinicaltrials.gov/ct2/show/NCT01147016?term=t+cells+breast+cancer&rank=4

If you have specific questions from a patient's point of view, please send me a private message through this message board. If you have questions about the treatment itself and your potential eligibility, please contact the study coordinators: Pat Steele 313-576-8721 or steelep@karmanos.org; and Karen Myers 313-576-8384 or myersk@karmanos.org.