Pancreatic Cancer Vaccine Trial Opens at NYP/Columbia’s Pancreas Center

by Columbia Surgery on May 26, 2011

M. Wasif Saif, MD, MBBS

M. Wasif Saif, MD, MBBS

Unlike some other forms of cancer, pancreatic cancer is often detected only in advanced stages, making it one of the most deadly forms of cancer overall. Surgical removal of tumors is possible in only 10% to 20% of patients, chemotherapy is not nearly as beneficial as patients and physicians would hope, and the risk of recurrence after treatment is high. Given these conditions, researchers are working hard to develop alternative therapies that extend patients’ lives past the average survival time, 20 months after diagnosis.

One of the most promising areas of research entails development of vaccines to harness the immune system to fight the cancer from within. An important study at NewYork-Presbyterian/Columbia’s Pancreas Center is now moving this concept one step closer to reality. The trial is studying whether a new vaccine, developed specifically to target pancreatic cancer cells, will help to prevent recurrences among patients who have had pancreatic tumors surgically removed.

The trial includes two arms: 350 patients will receive chemotherapy alone or with radiation therapy, and 350 will receive chemotherapy alone or with radiation, plus the new pancreatic cancer vaccine. Those receiving the vaccine will receive a series of injections, administered one month apart, beginning 8 to 10 weeks after surgery. Patients will be monitored every three months for the first 36 months, every 6 months for 2 years, and then annually to determine whether the vaccine helps to reduce the rate of recurrence.

The vaccine in this phase III trial was developed on the basis of a hypothesis called hyperacute immunotherapy. According to M. Wasif Saif, MD, MBBS, immunotherapy works by causing “hyperacute rejection:” in the way that other vaccines cause the body to develop an immune response against measles, polio or another disease, the pancreatic cancer vaccine triggers an immune reaction that leads to immunity against specific pancreatic cancer cells. In this case, the pancreatic cancer vaccine is produced using alpha-GT epitopes from mouse cells, which are not found on human cells. These epitopes cause a reaction that leads human cells to attack pancreatic cancer cells from within (called cell mediated immunity).

Data from a multicenter phase II study (preceding the current phase) showed encouraging results for this therapy. At 12 and 24 months after surgery, survival rates were 91% and 54% respectively, which is a significant improvement upon the median survival rate of 16 months. Patients are still being followed up to determine long-term survival benefits.

The phase III trial opened at NewYork-Presbyterian/Columbia in late April 2011. Dr. Saif strongly encourages eligible patients to consider enrolling in this trial. As he explains, “This is an important study for every patient and family member with pancreatic cancer. It is very important to come to centers that offer this study, and to understand that we now have more therapies to offer to patients with pancreatic cancer.”

To read about hyperacute immunotherapy for pancreatic cancer, see Dr. Saif’s March, 2011 article in the Journal of the Pancreas, Adjuvant therapy of pancreatic cancer: beyond gemcitabine. Highlights from the “2011 ASCO Gastrointestinal Cancers Symposium”. San Francisco, CA, USA. January 20-22, 2011.

For information about pancreatic cancer, treatments at the Pancreas Center, and other clinical studies, please visit The Pancreas Center.

{ 14 comments… read them below or add one }

Dr. Matthew Fineman July 20, 2011 at 8:36 am

Sirs: In Dec. of 2009 I discovered I had cancer of the pancreatic head growing down and obstructing the common bile duct. I received 23 TX of pin point radiation prior to having a Whipple procedure in April of 2010 by H. Leon Pachter, MD. I have just completed 12 weeks of chemo therapy and my CA-19-9 is 24. My last 2 PET scans were negative and I am scheduled for another one next week I am 71 years old and have been diabetic since age 50. I am controlled very well with Novalog and Lantus and my last HbA1C was 6.1. My question is would I be a candidate for this vaccine? I live in Punta Gorda, FL

Columbia Surgery July 20, 2011 at 5:52 pm

Dr. Fineman:

Thank you for the question.

I am going to forward your message to the Pancreas Center. Someone from that division will reply to you directly. In the off event, that you do not hear back from them please feel free to phone them directly at 212-305-9467.

The doctor in charge of the study is Dr. M. Wasif Saif. Information about Dr. Saif is available through the link below:

http://asp.cpmc.columbia.edu/facdb/pancreas/dir/profile_list_pancreas.asp?uni=mws2138&DepAffil=Surgery

Best wishes to you and thanks again for reaching out to us.

William Beal August 1, 2011 at 6:52 pm

Hello, I have recurrent Pancreatic cancer. I have been in remission for 2 years, and I am interested in any vaccine that may boost my immune system to fight off the disease.

Can you send me any information on a trial that you may have.

Thank you

Columbia Surgery August 2, 2011 at 9:34 am

Thank you for your request Mr Beal.

I am going to send your contact information to our Pancreas Center and someone from there should contact you shortly. In the off chance that you do not hear from them, please feel free to call 212-305-9467 or leave another message on this blog.

For additional information on the Pancreas Center, their web site can be found at http://www.pancreasmd.org.

Frank Hilson August 11, 2011 at 7:38 am

Sirs: I have Pancreatic Cancer Stage IIB, tumor grade III. I had resected surgery to remove the tumor in June 2010. I received chemo of Gemzar, 5-fu and 28 days of radiation. I finished those treatments in February. In June the cancer showed up in two of the periaorta lymph nodes. It was very small. I am now on a treatment of Folfox with 5-fu and something else. Is there anything else I can do to kill the cancer cells. What about a proton treatment or a vaccine? Please help…

Thanking you in advance for your help.

Columbia Surgery August 11, 2011 at 1:52 pm

Mr. Hilson:

Thank you for your message.

I suggest that you contact our referral line that can provide you with the name of a doctor you can consult with directly. The contact information for this line is:

Phone Number: 800-227-2762
Web Form: http://bit.ly/pueLef

They of course, could provide better help to you that what can be done over the Internet

If there is anything else I can do for you, please feel free to contact me back.

Elenita Lee November 19, 2011 at 6:16 pm

My sister is 63 yr. old and was diagnosed with Stage IV Pancreatic cancer in April 2011. She has been on chemo. since May 2011 with drugs, FOLFIRINOX. Recent CT scan showed some decrease in the size of the tumors in the tail of the pancreas as well as those in the liver and lungs. A bone scan however 2 days ago showed a tiny lesion in the right hi and one in the rib. She has had 14 cycles of treatment, but her CA19-9 still quite elevated.
Would she be a candidate for for this vaccine therapy ?

Columbia Surgery November 21, 2011 at 11:02 am

Thank you for your comment Elenita.

I am going to pass your message on to Dr. Saif in The Pancreas Center.

Since this is a specific medical question, you will mostly likely have to connect with Dr. Saif by phone at some point. You might just want to call his office number at 212.305.0592 to speed up the process.

If necessary, additional contact information for Dr. Saif and our Pancreas Center can be found here: http://bit.ly/rVpxNz.

If there is anything else I can help you with, please do not hesitate to contact us again. Best wishes to you and your sister.

Cathy Wirtenson December 2, 2011 at 9:46 pm

Please send me information on our vaccine clinical trial for pancreatic cancer. My husband had a whipple done in May 2011, he did 3 cycles of gemzar and then 28 days of radiation with xeloda, one month after treatment a tumor has now appeared on the liver. Plan to continue chemo, or try a clinical trial.
CAthy

Columbia Surgery December 8, 2011 at 6:53 pm

Cathy:

Thank you for your comment. I am going to forward your information to Dr. Saif who is in charge of this trial. If you would like to be proactive about this, he can be reached at 212.305.0592. More detailed contact information on Dr. Saif can be found here: http://asp.cpmc.columbia.edu/facdb/pancreas/dir/profile_list_pancreas.asp?uni=mws2138&DepAffil=Surgery

Please feel free to leave another comment, if I can help you in any way.

nlb December 29, 2011 at 10:15 pm

My father was diagnosed with a tumor on the head of his pancreas on April 17, 2011. A successful mini whipple was performed on May 3rd at Jefferson Hospital in Philadelphia (clear margins, cancer cells found in 3 of 15 lymph nodes). Six weeks later, after enrolling in the vaccine study and being placed in the control group he began the three stages of therapy – 1, gemcitabine, 2, radiation with 5FU, 3, back to gemcitabine. The tumor marker has been around 9 the whole time. However, now, while almost through stage 3, the tumor marker is up to 54 and there are cancer cells located on the top of the pancreas but nowhere else. He missed 2 or 3 treatments due to low platelet count. Thoughts on appropriate treatment from here on out?

arch January 10, 2012 at 3:08 am

My father has been diagnosed with advanced pancreatic cancer during his operation for resection of the tumor. Earlier doctor was sure it was a resectable tumor.
He had 4 cycles of gemacetabin along with tarceva, For two months he got symtamatic relief.But again symptoms bounce back and rise in level of ca count.Now he had 1 cycle of folflorinox.Along with gemacetabin he had 7 immunotherapy vaccinations .
Kindly let me know if my father could be candidate for this vaccines

Columbia Surgery January 10, 2012 at 6:05 pm

Arch:

Many thanks for your comments and questions.

We cannot provide recommendations or advice over the Internet, but I will forward your message and email address to our Pancreas Center. I also encourage you to give them a call at 212-305-9467 or visit their web site at http://pancreasmd.org.

Anything else, please feel free to contact us again.

Columbia Surgery January 10, 2012 at 6:55 pm

nlb:

Thanks for your comment, I will forward your message to our Pancreas Center, but please feel free to call them at 212-305-9467.

My apologies in taking so long to get back to you.

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