I had found the Lucanix study easily yesterday since it is the only vaccine-based study currently ongoing in San Diego. http://cancer.ucsd.edu/AboutUs/News/stories/Lucanix.asp.
Lucanix (belagenpumatucel-L) is a gene-based therapy in which tumor cells extracted from the host are modified in such a way that they inhibit secretion of a chemical growth factor that enables tumor cells to evade immune surveillance. The modified cells are then reintroduced to the host, where, by way of increased tumor antigen recognition, the immune system is rendered more effective in mounting a response.
It is a Phase III trial. Results of the two Phase II trials were promising: "Many subjects who received Lucanix™ at the same dose that will bee administered in this trial had long-term disease stability with a good quality of life. ...No significant adverse events were observed." http://clinicaltrials.gov/ct2/show/NCT00676507?term=lung+cancer+AND+san+die go+AND+vaccine&rank=2
Efficacy is to be evaluated in the third year (and ongoing for a total of 7 years), however an interim analysis will be performed at some midpoint. In either case, the vaccine has proven promising enough at extending survival (a 400% improvement in some subjects, which is remarkable) that the FDA granted fast-track status to this Phase III trial. If PhIII data prove as positive as PhII, the vaccine approval process will undoubtedly be fast tracked as well.
There is another Phase II/III vaccine trial (Recombinant Human EGF-rP64K/Montanide ISA 51), which has also showed promise in preliminary studies. It is recruiting but based in Malaysia.
There are additionally abundant studies going on locally at UCD and Sacramento, however most are chemotherapy-based trials. The sole vaccine-based study (GVAX, yet another immune response-enhancing autologous vaccine currently in Phase II, http://www.cancer.gov/clinicaltrials/SWOG-S0310) is for bronchoalveolar lung cancer; I gather yours is NSCLC. This study is no longer recruiting.
Basically, this entire field of endeavor looks to be very promising and is moving ahead with all due speed. Lucanix or some other autologous tumor vaccine will no doubt be appearing on the market in the not-distant future.
Already a member? Sign in
Welcome to Inspire!
What - Inspire is a place where you can connect with people who share your health concerns and find information and advice in groups sponsored by organizations you know and trust.
Why - As a member you can use Inspire to let friends and family know how you're doing, contact others who share your health concerns, receive personalized updates and information about participating in surveys and clinical trials, and more.
How - Joining Inspire is completely free and usually takes less than a minute. Join now!
Lucinex - Phase III trial ***HOPE***
- By kitkat4ever
- Posted May 14, 2009 at 1:19 pm · 39 replies
- In Non-small cell lung cancer - General
- Shared with the public
- Edited May 14, 2009 at 1:21 pm
Explore topics in this discussion:
Cancer Avastin Prostate cancer Decadron Chemotherapy Tarceva Carboplatin Lung cancer Folic acid
39 replies
- Oldest first
- Newest first
- By kitkat4ever
- Posted June 25, 2009 at 3:58 pm
- Report post
did you see the original post I made all about this vaccine and nsclc? Otherwise google it, although there are links in the article I posted.
yes, this is for nsclc. :-)
kat
- By candigrl63
- Posted June 25, 2009 at 1:59 pm
- Report post
hello. i thought the lucanex vaccine was for only breast, ovarian and prostate cancer? is there an article saying it was used for non small lung cancer? i would like to know the results if it was.
- By ION43
- Posted May 17, 2009 at 4:50 pm
- Report post
Hi KitKat and all others, I saw your initial posting on Lucinex just before I left on a vacation to Yosemite. I put in a quick call to my Oncologist plus two emails to the contact at UCSD and one phone call where I could only leave a message. At the oncologist's office, I was told to get all the information for her but they are usually contacted by the study team after the patient hooks up. Had my cell phone with me in Yosemite, received NO call backs from anyone and no return email. I'm stumped about where to go from here. Have you had any success? I think I meet the criteria right now but who knows where I'll be in two months? Nothing is easy with this disease.
Irene
- By kmhppl
- Posted May 16, 2009 at 9:02 am
- Report post
Hi Kitkat4ever and Sandy,
Thank you for doing all this research and sharing with all of us.I am very interested in this information.I am on Tarceva now but always am interested in new drugs that are in trial right now. I appreciate this very much.
Karen
- By molar
- Posted May 15, 2009 at 10:05 pm
- Report post
I did alimta for second line. It worked for 6 months. I was on that alimta/nexavar trial and by the standards of the trial I had to come off because 3 small nodules had grown by 20%. They can't measure my main tumor in the lower right lung because that part of the lung is collapsed. Anyway alimta wasn't too bad. I got it every 3 weeks and it made me very tired for about 3 days. I also got flu like symptoms, dizzy, nausea, vomiting 8 days after infusions and they figured out after 2 cycles that they had to taper the decadron over a longer period of time. You have to get B12 shots before starting it and then every 9 weeks and take folic acid orally while you are on it. My onc waited to do the gemzar so that I could miss the least amount of work possible. Alimta every 3 weeks, however, made me so tired that I usually had to take one extra day every 3 weeks to rest. I think alimta would certainly be an option for you if and when you need to switch to the next chemo. You might also consider tarceva. It seems to work well for the people that it works for. Hopefully your current chemo will work for a long time and you won't have to go on something else for awhile. However, I always like to prepare for the worst and hope for the best. Knowing what other options I have helps me to stay less anxious. That is why I guess I try to keep up on what all is available for treatment.
Sue M
- By kitkat4ever
- Posted May 15, 2009 at 9:30 pm
- Report post
Thank you for your reply, it is very encouraging for me.
Have you done Alimta?
- By molar
- Posted May 15, 2009 at 8:23 pm
- Report post
Wow, kitcat, we started gemzar on the same day. Throughout all my chemos, I have never had to take Procrit or Neulasta. My onc also does not do CEA levels. She does not think it is that accurate with lung cancer stage 4. However, I think every onc has their own opinion and every patient is different. In addition, I have a tumor in my lower right lung that has caused collapse of my right lung. I also have cancer nodules in both lungs. I had significant shrinkage of the cancer in the lower right lung with first chemo and have slight shrinkage or stable disease with all subsequent chemos until they stop working and had significant increase in number of nodules when tarceva did not work. A CT is what my onc uses but we already know that cancer is going to show up on the CT, so I guess there isn't much sense in doing a CEA in my case. In your case, I think your cancer has pretty much been obliterated, so a CEA is probably better for monitoring your progress.
I am hardly symptomatic even with the cancer I have in my lungs. I still work full time and if I didn't have this CT report sitting here, I would not even know I was sick most days. The onc always shows me a copy of the actual CT on disc and she is always so encouraging that I still have all this healthy lung tissue left. So I am very thankful for that.
Keep fighting.
Sue M
- By kitkat4ever
- Posted May 15, 2009 at 8:07 pm
- Report post
I started my Gemzar/Carbo again May 1 also. I do 2 weeks on and one off. today was my day off. I have a hard time as my RBC's go down, and I get anemic. BUT my Onc has me do Procrit and Neupogen for WBC's.
I did 6 rounds of Gem/Carb from Oct. 08-Feb 09 and got a clean PET, then my CEA started rising...
So hopefully its still effective because it is an easy IV infusion as far as little side effects.
Thanks. :-)
- By molar
- Posted May 15, 2009 at 7:36 pm
- Report post
Yes, I started gemzar May 1 and have had 3 treatments, including today. My blood counts were good, so my oncologist might add carboplatin. Gemzar is my 4th line. You probably don't remember, but my 3rd line, tarceva, didn't work for me, a great disappointment. That is when I went on gemzar and I have had very few side effects so far and it is by far the easiest IV chemo I have been on. First line was carbo/taxol/avastin, then avastin alone for 6 months and then alimta/nexavar trial for 6 months,then tarceva for 2 months.
My oncologist went to a research conference at Mayo this week. I am hoping she learned all kinds of info about new trials and the latest in some of the research. I am very interested in keeping up with all the possibilities for treatment.
Susan M
- By kitkat4ever
- Posted May 15, 2009 at 7:22 pm
- Report post
I think your best info would come from the trial site. and your doctor. are you in treatment now?
- By molar
- Posted May 15, 2009 at 7:08 pm
- Report post
Last fall the Lucanix trial had started at Mayo Clinic in Rochester, Mn. I keep current on all the trials conducted there, and my local oncologist's office in Cedar Rapids, Ia. runs some of the Mayo trials in CR. I asked about being in the Lucanix trial. However, I had slight progression of my stage 4 nsclc 6 months after my first line chemo, so I didn't qualify for the trial. I am interested in taking this vaccine. Am I correct in assuming that all sites conducting this trial have the exclusion that you cannot be in the trial unless you had stable disease or shrinkage of tumors with first line chemo and have shown no progression since then. I think I read that Lucanix (once approved) might be used even if you have had several different chemos. What is the understanding of others on this site? There certainly seems to be a lot of interest in this vaccine. Two of my co-workers saw something about this on MSN and were all excited thinking this might be "the one" for me. I'm still hoping it might be.
Susan M
- By lovlyles
- Posted May 15, 2009 at 2:50 pm
- Report post
Thanks Kit Kat.......I will take that deep breath and with the encouragement from all of you, hopefully we can get something accomplished.
Leslie
- By kitkat4ever
- Posted May 15, 2009 at 1:34 pm
- Report post
I am so glad this post is inspiring people.
leslie, take a deep breath and call the trial and lets all get this vaccine.
- By lovlyles
- Posted May 15, 2009 at 12:49 pm
- Report post
I was very inspired by your post Kit Kat. I have been on my soap box so much about big companies not letting promising cures come through and that everyone seems to be content with the barbaric treatments that I'm exhausted and right now I don't seem to have much fight in me.
I'm going to try and lift myself up a bit and look into this more. I'm so thankful for people like you and Sandy.
Leslie
- By claires
- Posted May 15, 2009 at 8:55 am
- Report post
Thank you for the post. It seems to move the goal posts a little closer!
- By jiminmpls
- Posted May 15, 2009 at 6:15 am
- Report post
Keep in mind that if they are still doing double-blind placebo based trials, that the effectiveness of the drug is far from certain. Typically, if the group receiving the trial drug shows significantly better response than the control group, they will end that study and enroll everyone in a modified study that looks at long term side effects and/or varying responses to different types of tumors, etc.
So, if you are in the control group receiving the placebo, you will be next in line to receive the drug if it actually works.
- By kitkat4ever
- Posted May 15, 2009 at 1:06 am
- Report post
Emergency Use Investigational New Drug Program for Oncology Drugs
Telephone: 888-463-6332
Description of Service: Through this program, patients with severe or life-threatening illnesses who are not eligible for clinical trials, and are in an urgent medical crisis, may be able to receive drugs not yet approved by the FDA to be used right away. The program is also known as the Compassionate Use IND Program.
Add to the discussion