DcVax experiences

8 Posts | Page(s): 1 

DcVax experiences

by johngiustino on Sun Jul 14, 2013 07:15 PM

Quote | Reply

Has anyone been enrolled in a clinical trial with DCVax?  If so, do you feel it is working?  If so, how far into the trial did you go progression free?

RE: DcVax experiences

by pooliepoo on Tue Jul 16, 2013 10:37 PM

Quote | Reply

I cant get in because of recurrrance but I was wonering if anyone paid oiut of pocket for it and how expensive it was.

RE: DcVax experiences

by M.nabil on Wed Jul 17, 2013 08:58 AM

Quote | Reply

Hi there,

if you scroll down in posts you will find a whole topic with answers regarding DCvax-L and similar products, http://www.cancercompass.com/message-board/message/all,72551

but i did contact NWBio the manufacturer of DCvax for my mom`s case and here is the replay.

hope it helps you :)

Dear Mohamed:
 
It was a pleasure to speak with you earlier.  In answer to your particular questions, I would note:
 
·         we have no means of acquiring tumour (fresh) tissues only paraffin saved ones.
 
The clinical trial protocol requires fresh tumor tissue.  Since your mother is not a candidate for the trial and since, in our conversation, we were considering whether she could possibly be a candidate for a Specials category of patient able to obtain the vaccine through a compassionate use/private pay option in Israel, we are able to manufacture DCVax-L with frozen tumor tissue that has no chemical preservatives.  As I mentioned in my earlier email, we typically need 2-3 grams of frozen tumor tissue to produce the tumor lysate which is one of the primary components of the vaccine.  Tumor tissue stored in paraffin is NOT usable for the production of the tumor lysate and therefore cannot be used to make the vaccine.
 
·         without any recurrence thats surgically operable we can`t start DCvax-L
 
Without 2 to 3 grams of untreated, viable, frozen tumor tissue, we will not be able to manufacture DCVax-L.   There are exceptions where we have made partial batches of vaccine, occasioned by the availability of lesser amounts of viable tumor tissue but that is not the normal course.
 
I would also note that we NEVER recommend surgery for the sole purpose of obtaining tumor tissue to produce the vaccine.  The only way we ever obtain tumor tissue from a patient is when the patient’s treating physician recommends surgery as a standard of care approach to managing that patient’s ongoing treatment.
 
·         DCvax-L is also for recurrent GBM?
 
Yes, we have produced DCVax-L for recurrent GBM patients who are eligible for the compassionate use/private pay option to obtain the vaccine.  As you know, the clinical trial protocol limits access to the vaccine to newly diagnosed GBM patients who meet other strict requirements.  Although we do not have reportable data on the success of administering DCVax-L  for patients with recurrent GBM, we have some anecdotal evidence of good results.  The course of any particular patient’s disease is extremely variable based upon the manifestation of their specific cancer and their physical condition.
 
·         we have to pay for the ENTIRE treatment cost  (compassionate use)? or we can pay initial 1st year or some doses
 
The manufacturing process for the vaccine is called a “batch method” meaning the entire three years’ course of vaccine is produced at one time.  As much vaccine as can be produced from the tumor lysate and the patient’s blood draw is produced, meaning some patients receive enough vaccine for several years (more than the clinical trial’s three year dosage schedule) and some patients only obtain enough vaccine for a few doses.  The payment required is for the manufacture of the vaccine and it does not vary based upon how many doses are able to be produced.  The accommodation that we have been able to grant is that, of the total $110,000 cost for the vaccine, $25,000 is due before the tumor tissue is delivered to the lab and the lysate production process begins.   Once we confirm that sufficient lysate was able to be produced, then the remaining $85,000 is due before we schedule the specialized blood draw known as leukapheresis and before the vaccine is manufactured.  Although the doses work out to be approximately $10,000 each (typically there are eleven doses given over the course of three years), the payment for the vaccine is due in full for the actual manufacture of the entire batch.
 
 
As a recap of our conversation, I would note that the vaccine is made from the patient’s tumor tissue (produced into a lysate which extracts the tumor’s unique biomarkers) and from the patient’s dendritic cells (isolated from a specialized blood draw).  Each step involves an intensive laboratory process requiring an extraordinary level of expertise and extensive quality control testing to ensure both potency and purity.   The production of the tumor lysate takes 8 to 10 days and then the quality control testing typically takes another few days.
 
Once the tumor lysate is made, your mother would then undergo a specialized blood draw called leukapheresis.  The monocytes (precursors to the fully developed dendritic cells) are separated out, purified and matured in the lab.  The blood from the leukapheresis must be processed within 20 hours after being drawn.  It takes 8 days to produce the vaccine and then it is sent for quality control testing, an additional 35-40 days.  The manufacturing process involves using the tumor lysate biomarkers to “educate” the dendritic cells to recognize the cancer cells.  It is our expectation that, when the vaccine is administered, the patient's immune system is activated and responds to fight the cancer. 
 
As you can tell, the length of time from the shipment of the tumor tissue to the administration of the first dose of vaccine is not short.  As a result, several significant timing issues must be addressed.  As I mentioned earlier, we always recommend that the patients follow their doctor's standard of care protocol.  We will work within that protocol to make arrangements for the procedures that need to be done and the timing of the DCVax injections.  In particular, there are challenging timing issues which arise in connection with both the leukapheresis and ongoing radiation.
 
Leukapheresis:
One concern that arises in connection with leukapheresis is the use of steroids.  The primary goal of this part of our process is to ensure the blood cells are as plentiful and vigorous as possible.  The administration of steroids affects the viability of the blood cells.  With regard to steroids, “less is better” and no steroids in the ten days prior to the leukapheresis is best.  Having said that, every person's cells are just a bit different, and for some people a low steroid dose (less than 2 mg/day) may not hinder a patient producing acceptable quantities of viable blood cells.  It is important to note that Northwest does not make medical recommendations so we do not dictate a particular patient’s steroid levels, but we do want to make you aware that if your mother is on steroids prior to leukapheresis, the risk of failure of the procedure is enhanced.
 
Radiation: 
As I am sure you know, radiation plays havoc with a patient’s immune system.  You indicated that your mother was beginning her standard of care protocol of chemo and radiation.  It usually takes at least 4 weeks for the monocytes to recover after a series of radiation doses and, even then, the quantity and quality sometimes do not fully recover.  That being said, we do have patients who have their leukapheresis about 10 days to 2 weeks after their radiation has been completed and the monocyte yield has been fine.   
 
We also discussed the issue of whether Egypt’s import laws will permit entry of the vaccine for administration by a physician in Egypt.  In the US, a patient can receive limited quantities of an experimental drug outside of a clinical trial, if it is part of a treatment plan that was begun outside the US.  We would need to explore Egypt’s requirements regarding administering the vaccine and how many doses could be imported into the country BEFORE we proceed with any manufacturing process of DCVax-L.
 
As I think I mentioned, the Specials program at King’s College in London is oversubscribed and is not an available access point for the DCVax-L vaccine at this time.  That means the only access point for a compassionate use/private pay patient is through a clinic in Israel where we have a collaborative arrangement.  The tumor tissue would be shipped to Israel and your mother would need to travel to Israel for the leukapheresis, where the vaccine would be made.  Your mother would then need to return to Israel to receive the first dose of the vaccine.  
 
I hope this information has been helpful in making the decisions which your mother and your family face.  There are no easy answers – as I mentioned before, DCVax-L is a treatment option and not a cure.  We are working very hard to cross the FDA’s approval threshold in order to make DCVax more widely available so that a patient’s treatment options can include more widely available access to the vaccine, with the hope that the length of a patient’s life can be extended and their quality of life can be enhanced.
 
Let me know if you have additional questions or if you determine there is frozen tumor tissue and your mother wishes to proceed.
 
I send you our best wishes for your mother’s health and strength and length of days.
 
Sincerely,
 
Carol
Carol L. Powers, Patient Liaison
For Northwest Biotherapeutics

978.697.2526 cell  (EST) 

RE: DcVax experiences

by RobinMB on Thu Jul 18, 2013 01:25 AM

Quote | Reply

Yes, my husband received a dendritic cell vaccine (it was not the DCVax from Northwest).  He had his treatment at Cedars Sinai in Los Angeles, CA.  He was, initially, diagnosed in Feb. '12.  He had STUPP protocol, and he had a recurrence in June '12.  At that time, he received a second craniotomy to remove the two new tumors in the original resection cavity.  The surgeon found inoperable tumor near the corpus callosum. Then, the vaccine was created.  In September, his MRI showed no tumors in the original cavity, but the inoperable tumor remained. 

Subsequently, my husband continued with Temodar.  Avastin was introduced in December.  The inoperable tumor was stable up until May '12.  Now, it is approx. 3 x 3 cm. and his treatment now includes carboplatin and etoposide. 

We are now 18 mos. into this dreaded cancer.  My husband suffers from extreme fatigue (I think a lot of it has to do with depression).  He has not tolerated the carboplatin and etoposide well.  His WBC and platelet counts went down drastically. 

We are looking into additional clinical trials. 

I wish all of you well.

Robin from NY

RE: DcVax experiences

by iaklevy on Thu Jul 18, 2013 02:00 AM

Quote | Reply

On Jul 18, 2013 1:25 AM RobinMB wrote:

Yes, my husband received a dendritic cell vaccine (it was not the DCVax from Northwest).  He had his treatment at Cedars Sinai in Los Angeles, CA.  He was, initially, diagnosed in Feb. '12.  He had STUPP protocol, and he had a recurrence in June '12.  At that time, he received a second craniotomy to remove the two new tumors in the original resection cavity.  The surgeon found inoperable tumor near the corpus callosum. Then, the vaccine was created.  In September, his MRI showed no tumors in the original cavity, but the inoperable tumor remained. 

Subsequently, my husband continued with Temodar.  Avastin was introduced in December.  The inoperable tumor was stable up until May '12.  Now, it is approx. 3 x 3 cm. and his treatment now includes carboplatin and etoposide. 

We are now 18 mos. into this dreaded cancer.  My husband suffers from extreme fatigue (I think a lot of it has to do with depression).  He has not tolerated the carboplatin and etoposide well.  His WBC and platelet counts went down drastically. 

We are looking into additional clinical trials. 

I wish all of you well.

Robin from NY

so sorry to read about this, cancer is just something I never expected to deal with myself and I know how you feel. My husband has braincancer and much of the time he just sleeps and is not comunicating much. His cancer is a astrcytoma 3rd stage and he went thru chemo, cyberknife, radiation. He is treated at the Seattle,  Swedish Hospital, his Dr. was happy with his last MRI there was no growth to it. Unfortunatly there is no prediction like in so many cancer cases and I still hope it will shrink ore just dissapear. He is depressed and dosn't want to do much he is cold all the time and needs a blanket most of the time even though we have been in the low 80th the last week. I hope you will find a clinic where the can help you.

I know Swedish has a new clinic in Issaquah, WA. where my husband had the cyberknife treatment. Maybe the have an answer for you. Stay strong as we all try to do...

RE: DcVax experiences

by rbmorris on Fri Nov 08, 2013 10:43 PM

Quote | Reply

My wife was diagnosed with state 3 stomach cancer in April of 2012.  She went through a round of chemo, then had 85% of her somach removed then another round of chemo.  She was doing fine until about 3 months ago when she started having shoulder pain.  We now know that the cancer has returned and shown up all over her body including bones.  She's in terrible pain and almost completely bedridden.  The doctor thinks she's down to months at best but judging from her condition, I would be surprised if she makes it much longer.  My question is does DcVax offer any hope and if so, how do we proceed?

RE: DcVax experiences

by johnlane45 on Sat Nov 09, 2013 02:53 AM

Quote | Reply

She would need to qualify but contact MD Anderson in Houston and see if she can get in to DCVax-Direct. This vaccine provides some hope....it is worth a try. God bless and good luck!

Locations
United States, Florida
MD Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Mollie Geismer, RN, PhD, CCRP     321-841-5206    Mollie.Geismer@orlandohealth.com   
Contact: Kristine Moore, RN, CCRP     321-841-7612    KristineMDAResearch.Moore@orlandohealth.com   
Principal Investigator: Omar Kayaleh, MD            
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Vivek Subbiah, MD     713-563-0393    vsubbiah@mdanderson.org   
Principal Investigator: Vivek Subbiah, MD            

 

RE: DcVax experiences

by rbmorris on Sat Nov 09, 2013 09:48 PM

Quote | Reply

On Nov 09, 2013 2:53 AM johnlane45 wrote:

She would need to qualify but contact MD Anderson in Houston and see if she can get in to DCVax-Direct. This vaccine provides some hope....it is worth a try. God bless and good luck!

Locations
United States, Florida
MD Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Mollie Geismer, RN, PhD, CCRP     321-841-5206    Mollie.Geismer@orlandohealth.com   
Contact: Kristine Moore, RN, CCRP     321-841-7612    KristineMDAResearch.Moore@orlandohealth.com   
Principal Investigator: Omar Kayaleh, MD            
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Vivek Subbiah, MD     713-563-0393    vsubbiah@mdanderson.org   
Principal Investigator: Vivek Subbiah, MD            

 

Thanks for the reply.  I'll definitely look into it.

8 Posts | Page(s): 1 
Subscribe to this message board discussion

Latest Messages

View More

CancerCompass Survey

If you were considering traveling for cancer treatment, which headline would you find more interesting?

Get $75 for taking a research survey

We care about your feedback. Let us know how we can improve your CancerCompass experience.