Thursday, January 27, 2011

New Clinical Trial: for EBV positive tumors.

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As of recent (the last ten years), Baylor Hospital College of Medicine in Houston, Texas has been creating a clinical trial as a vaccine for Hodgkins patients (especially relapsed and refractory) for those who have tumors that are EBV positive. I believe, after research, and watching a few other warriors go through this vaccine who are EBV positive (we carry a virus, in our immune system that is the causation for mono), that this is a major key component to some of us who have very, very stubborn disease.  Dr. Bollard, who is in charge of this study down in the heart of Texas explains the process much better than I do.

So, I am copying and pasting her email to potential patients for those of you who have refractory/relapsed HL.  Believe it or not, there are two different arms of this study (one for those who have relapsed and are in current remission, and those who still have disease). So whether you are in remission (like me right now!) or are currently on clinical trials. You should definitely get your tumor block tested for EBV positive tumors. This can be done by contacting Dr. Bollard, and sending her your tumor block.  The process of this trial takes about 4-5 months, in October, I was lucky enough to start -- and now the infusion I will receive is ready, and I will receive it once we receive the results of my next PET/CT scan on February 17th.  Either way, if I am in remission or not -- we have a plan.

Here is the email to potential candidates for this trial: please, please consider it if you have relapsed, and get your tumor tested for the EBV virus.  This trial has had phenomenal results, and it is more of a vaccine opposed to 'treatment' or chemo.

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Thank you for you interest in our T cell studies for EBV lymphoma. Our current protocol uses autologous LMP1 and 2-specific Cytotoxic (killer) T cells (CTL) either as therapy for relapsed EBV+ve Hodgkin Disease (HD) or non Hodgkin's Lymphoma (NHL) or as adjuvant therapy after autologous OR allogeneic transplant.

In our previous studies, we successfully generated EBV-specific CTL in patients with EBV-positive Hodgkin's lymphoma (Roskrow et al, 1998 and Bollard et al 2004 J Exp Med). However, only very small percentages if any of them were LMP2A- (or tumor)-specific. These small populations of LMP2A-specific CTL did however induce complete remissions in some patients but we were unable to eliminate the EBV-positive Hodgkin's lymphoma in patients with bulky disease. In patients who received the CTL as adjuvant therapy post autologous stem cell transplant all remain in complete remission over 7 years later. In patients with bulky disease it is possible that LMP-specific CTL have good killing ability in these patients but that their low frequency precludes effective tumor elimination. We therefore went on to expand LMP2A-specific CTL in the laboratory in large numbers from patients with relapsed lymphoma and treated 30 patients on this protocol and saw complete clinical responses in 80% patients with active EBV+ve Lymphoma. Only one patient who was in remission at the time of CTL has progressed with the rest remaining in remission over 5 years. We have now started 2 new protocols generating T cells specific for both LMP1 and LMP2 (LMP1 and 2 specific CTL). LMP1 and LMP2 are the EBV proteins present in about 20% of patients with Hodgkin disease and NHL and these T cells that we grow from the patients in the laboratory should recognize and kill tumors positive for EBV.  We have not seen any toxicity with these studies but they work best in patients with relatively minimal disease.

If you are interested in this study the first thing to do is to send me a copy of your pathology report confirming EBV positivity of your tumor. This can be emailed to me or faxed to me at 832-825-4732.

The other issue is that the entire CTL production process can take 3-4 months depending on the patient so we would want to collect blood at the earliest point possible to initiate the EBV-transformed B cell line (LCL) which we use as the antigen presenting cells. Ideally we will first collect your blood, the nurse practictioner  will contact you to get your details and send a (blood) kit to you. Once you have the kit with the blood tubes and the consent form and the donor questionnaire I will call you to get the phone consent to draw the blood.

You would have to sign a consent form to consent to the procurement part of the study (i.e. giving us permission to make the CTL lines) only. You would have to donate approximately 60mls of blood on two separate occasions. As I said above, the consent can be obtained on the phone and the blood can be shipped to us. If it is possible to grow T cells (CTL) from you - once they are made and if you were eligible after autologous stem cell transplant and wanted to participate then you would have to come to Houston twice to receive the T cell infusions.


Kindest regards,

Catherine Bollard,MD
Associate Professor
Texas Children's Cancer Center,
Baylor College of Medicine
6621 Fannin Street, MC3-3320,
Houston, Texas 77030
phone:1-832-824-4781
fax:1-832-825-4732
Email: cmbollar@texaschildrenshospital.org

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Please look into this study warriors! I personally know two individuals (one who has continued remission for over four plus years), that this has been successful for.  It's this new stuff on the horizon that makes me hopeful!

Sending love and light,
B!