Abagovomab vaccine trial?

What would you do in my situation? I've just completed 6 rounds of chemotherapy for stage 3 serous papillary adenocarcinoma, high grade. I've been asked to take part in a phase 2 (vaccine) study for abagovomab.

Abagovomab is a mouse protein that resembles CA-125. The HOPE is that if they inject this protein, my body will start to build antibodies for the protein, and once the antibodies are present, they will be able to attack any ovarian cancer cells that appear. At this point, it's not proven, but the study aims to prove that it works.

My concerns:
1. If I join this study, my CA-125 can not be used to monitor for recurrence. I would have to rely on CT scans only. I know CA-125 is not perfect, and neither is CT scans, and I'm concerned about that.

2. It's a 2:1 ratio (which means that I have 1/3 chance of receiving placebo) and won't know that I have placebo (and CA-125 will not be able to be used anyway even though in this case it would be accurate - hope that makes sense).

3. It's only in Phase 2. I work at a pharmaceutical company and I know how very MANY phase 2 drugs wind up doing absolutely nothing.

4. If a better drug / vaccine comes up that happens to utilize mouse protein, I will NOT be able to enroll in a clinical trial for that drug. I know new and improved drugs come up all the time.

My oncologist is concerned about the high grade of my cancer, and said she would still take the chance and go on the study. Her reasoning being that we want to do anything we can to prevent a recurrence in the first place.

A friend of mine who has worked in oncology (at a pharma company) for a long time said in his opinion (based on the vaccine being only phase 2, etc. my reasonings 1-3 above) he would not take it. He was also concerned that since there are only 2 ways to monitor, CT-scan CA-125, and neither is perfect, taking one away could cause the drs. to miss any possible recurrences while they are small.

What are your thoughts?

By Martha2
Posted June 24, 2008 at 8:11 am
Report post

Hi Renee,
I completely understand all of your reasoning. I've been through all the pros and cons of going on a Phase 2 trial and have been on one and am hoping to go back on it when it restarts. That said, imagine if a vaccine came along that would turn out to be the one that really works but we never found out because nobody was willing to take a chance on it. Even if the vaccine you're contemplating isn't the one, the scientist will learn something from it. I don't know how long your study would last (in terms of not being able to use your CA-125 as a marker) but you could do it for a while and see how it goes. I'm assuming that like most trials you can quit when you want. My husband who is a pharm researcher says that cancer vaccines are the way of the future. Trials are scary and not for everyone. Whicheveer way you go, my best wishes for you.

By Dee5
Posted June 24, 2008 at 10:13 am
Report post

I looked into a vaccine trials but was just outside the window for when I could participate.

Would your doctor be willing to use the "new" Yale test ( multiple markers) to follow you if you join the study?

Also what was your CA-125 prior to diagnosis? If it wasn't elevated CT scans and pelvic exams might be the best for follow-up any way.

Having done the clinical trial route I understand your concerns and questions.
Dee
Edison
Dx 7/2005
Selenium/carbo/taxol

By ReneeK1
Posted June 24, 2008 at 11:34 am
Report post

Hi Dee, before my operation, it was 296 if I remember correctly. My latest test results show it as 10. I will look up the new Yale test, and learn about it myself, then ask Dr. Sabbatini about it when I meet with him. Thanks for suggesting that!

By ReneeK1
Posted June 24, 2008 at 8:24 pm
Report post

Wow, talk about timing. Thank you very much, Dee! This just posted. Any one of us can go to Labcorp for a more accurate test now. Yippee!!
https://www.inspire.com/CaraPolicy/journal/ocna-encouraged-by-release-of-ov asure-test-for-ovarian-cancer/?msg_activity=reply_posted&page=last&cmnt_id= 21691

By Martha2
Posted June 25, 2008 at 8:11 am
Report post

Hi Renee,
Another aspect to consider in doing a vaccine trial is that they are usually only open to patients between their initial diagnosis and first reoccurence. If you have a reoccurence, chances are most likely that you wouldn't be eligible anyway if a more promising vaccine came along.

By artattack59
Posted June 25, 2008 at 11:44 pm
Report post

Reneek1:
Are you sure it is a phase 2? I belive the phase 2 abagovamab is completed. I am in that trial with Dr. Sabbittini at Sloan Kettering NYC and it is a phase 3. I too was afraid of not being able to use my CA125 But I knew I would be more closely monitored being in a trial. You will have more supervision than if you do nothing.( You have blood tests and cts every three months and a pelvic exam once a month). I just couldn't just sit around waiting. And as other posters have mentioned, trials allow us to do something for "the cause". it is a comparatively non invasive study. The worst side effect is a sore arm and some rash if you are not in the control group. Got to: govtrials.org. or google "Mimosa Trial" for more info.
Lisa

By katie52
Posted June 26, 2008 at 8:44 am
Report post

Hi Renee,

I have been in this clinical trial since 1/07. I understand your concerns, particularly since it is a major time commitment. One thing to keep in mind is that if patients do not participate in clinical trials then there is no way for new treatments to be developed. You must enter this trial within sixty days of completing chemo and be cancer free. If you do not enter now, you cannot enter it later. This trial is specifically designed to try and prevent a recurrence of cancer.
I work for a cancer research institute and asked my scientists to review the paperwork before I chose to participate. They were very supportive of what they read and encouraged me to join. Also, my oncologist, Dr. Konner attended a conference this year where this trial was discussed and he said that it was very positive.
Good luck in whatever you decide.
Katie

By sbender3
Posted June 26, 2008 at 5:36 pm
Report post

hello, my concern with all clinical trials is one of your concerns, and it is the most valid one. you never know if you are getting the drug or not, so if you are not, you are then at risk for deteriorating your own health. the problem i have with our medical trials, and our country, is that people should be able to get the drugs in these trials, and use them outside of the trials, if they so choose. there are several states in the us that allow this, and require insurance companies to pay for the experimental drugs. it is our life, and we should have the chance to know for sure we are getting the drug, and not risking our lives for nothing. i understand clinical trials are for the greater good so to speak, that really doesn't do that much for us now does it. i am not trying to sound uncaring, but in other countries, they do not hang up the drugs as long as we do in the u s, and they also allow their patients to decide what they want to do when all else fails, if they want to get into experimental drugs, they are allowed, and i have seen some research tha shows they have better survival rates in the other countries, especially europe, than we do, and that is sad!!!!! god bless you, and i wish you the best in whatever your choice, and you and all are in my prayers. sherry

By Martha2
Posted June 27, 2008 at 11:56 am
Report post

Hi, I just wanted to respond to what Sherry wrote about clinicial trials. She mentioned that since you don't know if you are getting the test drug or a placebo in many clinicial trials you're putting your health at risk. What is important to remember in these trials is that your health is being followed much, much more closely than if you were just being followed routinely. Chances are you would have blood tests every week and CT scans probably 50% more often than you would not in a clinical trial. Many of the clinicial trials that are testing new treatment (as opposed to vaccines) test the new drug along with an older established drug so that your cancer is being treated by the new drug or by a standard treatment - you just don't know which one you have but your cancer IS being treated by some drug. Clinicial trials save the lives of many of the participants on them. Clinicial trials are not just about treatments for the future - very often they help the participants now.
Also, as for the FDA not approving treatments fast enough just look at the lawsuits that already claim the FDA is rushing drugs to market. That is not the fault of the government - that is the fault of comsumers who sue companies and the FDA. if eveyone wasn't so scared of lawsuits and having to spend billions defending themselves, there would be much more money that could be spent on medical research and care.

By carla75
Posted June 27, 2008 at 1:17 pm
Report post

Hi Renee,

I have an appointment with Dr. Sabbatini in NYC to discuss this trial - and I'm under the impression that it is in phase III. I share the same concerns as you...especially the CA125. But I feel that if I didn't investiate it further, I'm not being proactive in my own health care. It may be a great opportunity to recieve a promising drug....or a chance to be a pioneer for a great cause. It's a tough decision, but I'm hoping to get some more clarity after today's appointment. Good luck in your decision.

By ReneeK1
Posted June 27, 2008 at 9:12 pm
Report post

Hi all, thanks for all of the responses. I appreciate all who weighed in. Between this thread and the other I read on this same board, I'm definitely interested in the trial -- today I went for my 6 month post-surgery checkup with Dr. Levine (my surgeon -- who works with Dr. Sabbatini on many things). He strongly agreed with my oncologist this is the way to go.

At this point, I've had surgery, done 6 months of chemo, responded to the chemo with a CA-125 of less than 12 (which Dr. Levine says is GREAT). He said if the cancer ever by chance comes back (and we all know those statistics at stage 3), it can then at that point only be managed- but not cured with the drugs they have available at this time. So we want to do all we can with what we have available to have it NOT come back in the first place. And this is pretty much it.

So I'm going to go on the study. Carla, were you in NYC today? I was there too! Dr. Sabbatini is on the same floor as Dr. Levine...

By sbender3
Posted June 28, 2008 at 3:19 pm
Report post

HI MARTHA-I AGREE ABOUT LAWSUITS, WE LIVE IN A SUE HAPPY SOCIETY. I JUST WISH EVERYONE HAD THE RIGHT, AS THEY DO IN SOME STATES, TO HAVE ACCESS TO ALL THE DRUGS THAT HAVE PASSED INTO I THINK IT IS PHASE 3, AND THAT INSURANCE COMPANIES WOULD HAVE TO PAY FOR THE TREATMENTS. IT IS JUST LIKE GOING TO THE CANCER TREATMENT CENTERS. I HAVE ANTHEM, AND THEY ARE OUT OF NETWORK FOR ME TO GO TO ILLINOIS, EVEN THOUGH IT IS BLUE CROSS BLUE SHIELD. I AM FORTUNATE THAT WE FOUND AN EXCELLANT DOCTOR HERE, BUT A PERSON WITH INSURANCE SHOULD NOT HAVE TO MORTGAE THEIR HOME TO SAVE THEIR LIFE. AND GOD HELP US IF THE GOVERNMENT GETS INVOLVED IN OUR HEALTHCARE, I DON'T KNOW WHAT COUNTRY WE MIGHT HAVE TO GO TO , IF WE WANTED TO LIVE! I AM AN INSURANCE AGENT, I HAVE BEEN IN THE BUSINESS FOR MANY YEARS. THE PROBLEM WITH OUR COUNTRY IS THE DRUG MANUFACTURERS. 10 YEARS AGO, PHARMACY COSTS REPRESENTED LESS THAN 10% OF THE CLAIMS FOR MEDICAL SERVICES, TODAY, THEY REPRESENT 50 TO 60%. TOO MANY PEOPLE ARE ON DRUGS THAT CAN KILL THEM, WHILE PEOLE WITH CANCER AND DISEASES THAT WANT TO TRY AND BATTLE AND LIVE STRUGGLE. THAT IS MY POINT. WE ALL FACE THE SAME UGLY DISEASE, AND WITH THE LORD BY OUR SIDE, WE WALK THE WALK WITH OUR HEADS HELD HIGH. GOD BLESS, SHERRY

By katie52
Posted June 30, 2008 at 9:18 am
Report post

Hi Renee,

I am glad to hear that you decided to look into this clinical trail. I just wanted to point out that in the most recent issue of Women in Cancer there an article on the importance and success of clinical trials.

Good luck!

Katie

By Brandi
Posted July 8, 2008 at 11:35 pm
Report post

I am considering participating in the same clinical trial with the Abagovomab vaccine and I have pretty much the same thoughts/concerns as ReneeK1. I have (had?) stage IIIC ovarian cancer. I had surgery in December 2007 and finished 6 rounds of IV/IP chemo in May 2008. I am talking to the research nurse about the study on Thursday. I am just curious to see if ReneeK1 has any further thoughts after her appointment with the research doctor in NYC. Thank you to everyone who has shared thoughts about this.

By ReneeK1
Posted July 8, 2008 at 11:51 pm
Report post

Hi Brandi, my appointment with the research doctor isn't until tomorrow, but Dr. Levine, my surgeon, pretty much convinced me (see my post jun 27), so I think I'm most likely going to take the chance.

I'm hoping with that new blood test, the CA-125 issue will be pretty much moot...I am going to ask about the new blood test tomorrow when I go and see if we can use that for monitoring since we can't use CA-125 anymore.

The only other open issue is insurance coverage, I want to find out how much I'd have to pay myself per visit. After tomorrow, I will call the insurance company to see if they cover clinical trials, if not, will they at least cover the costs of what would be considered "standard of care", the dr. visit, the quarterly CT scans, etc.

By Brandi
Posted July 9, 2008 at 12:13 am
Report post

Hi Renee

I hope that your appointment is very helpful and that you are able to make a decision that you feel very good about. I feel so lucky that I found this conversation string when I googled the vaccine. I have been going back and forth about joining this trial. I had surgery and treatment at Cedars Sinai in Los Angeles and I had a post treatment 2nd opinion consultation with a doctor at the USC Norris Cancer Center. My doctor at Cedars didn't even mention the study but the research nurse at Cedars did. I have been communicating with the Dr. at USC and she seems to think that it is a good option for me. I have to re-read the study documents and think about it some more. One question I have is If I were to get the placebo instead of the drug and my CA-125 levels increased even though I couldn't see them, would I get dropped from the study and then be able to seek treatment? I am willing to share information I learn from my conference with the research nurse and my doctor (if I can reach him...) and I wonder, would you be willing to share information / thoughts from your meeting with Dr. Sabbatini? Thanks so much for starting this string. It was an answer to a prayer. I am struck by how many younger ladies have been diagnosed with stage IIIC ov cancer. I almost thought I was the only one. I wish we weren't all "meeting" like this.

Best to you for tomorrow!
Brandi

By ReneeK1
Posted July 9, 2008 at 12:21 am
Report post

Hi Brandi, I know from double-blinded studies that not only do you not know what you are receiving, the doctors also do not know. (Therefore, if you are on placebo, no-one will know, so they will have to treat your blood results as if you were on active, i.e. the CA-125 can't be used).

I believe with this study they will not rely on blood tests at all to determine if there is a recurrence, but rather the CT scans (for all patients, placebo or active because no-one involved will know who is on what treatment arm).

I will definitely double check tomorrow though. And also will be asking, since they can't use the CA-125, if they can use the new blood test that is out.

By momanderson920
Posted July 9, 2008 at 7:45 am
Report post

After your 6 treatments are you in remission now? And how long would you be on this trial? I didn't see if you had included that information. And does your doctor do PET scans or could they be done during the study? I had a CT without contrast that did not show my cancer and the PET did. It may have shown up with the CT with contrast but I could not have it due to kidney issues.

By momanderson920
Posted July 9, 2008 at 7:48 am
Report post

Also, when I was offered participation in a clinical study, I was told I could quit at any time. They don't prefer it, but I could do it. It turned out I didn't qualify for the study due to kidney problems and I had to be put on high dose prednisone. If you start having symptoms while on the drug, maybe you could quit and go on a chemo regime. Will they do a CT with contrast during the study and how often? Also would the OVASURE test be an alternative to the CA125 test or would that be ineffective also?

By katie52
Posted July 9, 2008 at 9:01 am
Report post

Hi,

I have been in this trial since 1/3/07 and I have a CT scan, blood tests and an internal exam every three months. You will recieve your shot evey 28 days. If a patient were to have a recurrence during the trial they would need to drop out and begin chemo again. According to the papers that I received your participation in the trial will be anywhere from 2 to 4 years, but you are free to drop out whenever you want. At MSK they say the trial is for two years, but the papers from the company say 2 to 4 years. I am willing to stay in it for as long as they want because clinical trials are a major part of developing treatments for cancer.

Good luck,

Katie

Welcome to Inspire!

Explore topics in this discussion:

28 replies

Add to the discussion

OCNA on Twitter

Group leaders

You