Clinical Trials

[JeffInNYC]

Some of you may be able to offer some insight on this.

Anyway, its my mom.  She had been doing remarkably well and has been responding to her treatments for ovarian cancer.  Unfortunately, it turns out she is platinum resistant and is already having a recurrence.  Of the drugs currently FDA approved, this was her best chance.  But unfortunately most women DO recur but I was hoping it wouldnt have happened so quickly.

Her oncologist and surgeon want her to get into this clinical trial for this new drug in phase 2 and phase 3 clinical trials (same drug but different trials for the way its administered).  Apparantly they have had some good success with this new drug and someone else is now looking through her file to determine is she is a good candidate for the trial.  Im praying she gets selected.  Im hoping her doctors have enough clout to get her in.

I would like to think if this drug is being used in a phase 2 and 3 trial, that it must show a lot more promise than whats currently out there.

My question is, if her oncologist and her surgeon are talking about getting her in, can the "selection committee" still turn her down?  Do drug companies tend to weed out candidates because they purposely want the best results possible for the trial?  Her life is at stake here and I want to fight for her.  Whether you know me, dont know me, like me dont like me, this is for my mom and if anyone can possibly shed some light on clinical trials I would sincerely appreciate it and be grateful.

Sorry for the serious topic  But I will do anything to get any information that could possibly help my mom. I have been on the phone all day trying to get info.  Its the least I can do for her.  All my crying isnt helping but maybe I can get information that could somehow help her.  Im desperate.

Please keep good thoughts for her.

Thanks.

[Matty the Damned]

Jeffina,

Clinical Trials are conducted under strict scientific rules. The companies and institutions don't interfere in the processes to get the best outcomes. If your mother meets the selection criteria I would imagine she'll get in. If she isn't selected then it's because she's not eligible.

MtD

[HIVworker]

I'll say this from the outset. I do work for a pharma company but in research and am not involved much with the clinical trial process - that said my knowledge is incomplete. What I do understand is that patients are not weeded out based on getting "good results" that will make the drug look better than it is. Frequently the criteria are designed to look at patients that, for example, do not have other conditions that will cloud the results that they will get. It is hard, in this example, to accurately discern whether the drug is doing what it is predicted to do - whether side effects in early clinical trials are due to the other conditions or the drug. In addition, for cancers, some drugs are more effective for certain stages of cancer. So such drugs are not useful at certain cancer stages - so the trials weed out patients that the drug is not designed to help. The decision to include patients in a clinical trial therefore is based on the science on what the drug is designed for and what biomarkers the patient can provide. Such patients with known reactions to certain sorts of drugs will be excluded based on any safety data.

That is what I understand the process does and the FDA is heavily involved in this decision to protect the patients and to ensure a clear as can be had look at how the drug works - whether it does at all.

Rich

[ademas]

I would think if her oncologist and surgeon want to get her on it, and are trying to get her in, chances are she meets the protocol. 
I would move on it as fast as possible.

[fearless]

hey Jeff,

Sorry to hear about your mum.

As Matty and Rich said, there will be criteria but these are not designed around weeding people out to get good results but rather they are designed to get accurate results. The criteria and trial protocols go throught a number of ethics and other committees for approval to ensure that any findings will be scientifically valid.

With the trial I am on, the screening phase involved a number of tests - blood, ecg, blood pressure etc, and a look into my medical history and that of my family. I almost didn't make it because I tend to have a peculiar heart beat, which both my mum and her sister have. In the end they let me in though.

Even if accepted onto the trial, it will most likely involve a placebo or control group who will not be taking the new drug, so there is no guarantee she will get the new drug. I'm in the control group on my trial so am taking already approved drugs; Kaletra and Truvada. Trials aren't for the faint hearted either. While they do take good care of you and treat you with respect, you must remember that the primary purpose of the trial is to test the efficacy of a new drug and not treating your mother. They can seem a little impersonal at times and in a sense you are a lab rat. A strong committment to the trial is necessary and the capacity to give a fair amount of your time in accordance with their timetable.

I hope that doesnt' turn you off, as participating in a trial can be quite rewarding.

I hope all works for her.

Stephen

[JeffInNYC]

Dear Stephen,

Thank you for sharing your experience and for giving such a great response to a very important issue.  In my moms case it will be an open label study...meaning she will know exactly which drug(s) she is getting. In this case, and maybe cancers in general, there really is no placebo...meaning she is getting treatment, just not necessarily in combination with the trial drug.  Assuming she is admitted into the study, she has a 50% of getting the trial drug...its all randomized.

Ovarian cancer is a very serious and deadly disease.  Unfortunately, most women are diagnosed in the advanced stages due to lack of symptoms or subtle symptoms.  Its important to get the word out about this nasty disease and its especially important for women to go to their doctors when they are experiencing any subtle symptoms.  They should INSIST on getting a CA-125 test and a transvaginal ultrasound.  This could happen to anyones mother, sister, daughter, etc.

The last several months have been a total nightmare for my family - especially for my mom.  It truly is heartbreaking.

I just wish there would be more publicity or fund raising or research being done.  Great strides have been made but its just not enough and its unacceptable that 20+ years after Gilda was diagnosed, that there is still not a proper screening for this disease to catch it in early stages.

[HIVworker]

Jeff,

More always can be done, more money, people and education are always needed. Just look at HIV. However, there are people involved in ovarian cancer that are as passionate as those involved in HIV. People constantly thinking of the problem and trying to solve it. What I am trying to say is that there is always hope.

You and I have passed PMs on this subject and I wish I could help more. All I can do is follow this story here and hope for the best resolution possible, I am almost certain your AIDSMEDS family feel the same.

Keep us informed...

Rich

[Eldon]

Hello Jeff,

I just wanted to wish you the BEST for your mom with these clinical trials.




Make the BEST of each Day!

[JeffInNYC]

Thank you.  I appreciate all the good thoughts.

[Eldon]

You are more than welcome. We are here to support each other.

[Christine]

Hi Jeff,
I have been on four clinical trials. There are criteria that exist for the trials, but it is not a weeding out process to ensure the results end up in a certain way. For the hiv trials I have been in, some of the criteria have been t-cells counts, vl load counts, drugs that I have been on, genotype and phenotype results. I have never been turned down for a trial. I have found the doctors and nurses advocate very much on the behalf of the patients.

There is a IRB- Institutional Review Board which works with the hospital or doctors office to make sure the study follows guidelines. I have had good experiences with the trials, and have found the study nurses, and all the doctors to be very professional and respectful of me.

Here is a web site that lists all clinical trials: http://www.clinicaltrials.gov/

I am sorry with everything you and your family have gone through. Big hugs to you.
Christine

[JeffInNYC]

Thank you Christine.  The one we're trying to get my mom enrolled in has been put off for a week or a few weeks because the hospital didnt get approval from the IRB. Do you have any idea how long it will take the hospital to get approval?  Is there anything I can potentially do to speed up the process?

Time is of the essence.  My mom will shortly need more chemo...but once they give her more chemo, she will not be eligible to participate in the study. Its imperative the hospital gets approval asap and we get my mom enrolled.  Even then only a 50% chance she will be the one randomly selected to get this new drug.

Thanks again Christine and hugs right back to you.

[HIVworker]

Contact the drug company that makes the drug. Often they will have an enrolment website that you can look at. If you are lucky, there will be more than one hospital in your area in the study that might be further down the line of approval.

Rich

[Christine]

Hi Jeff,
I don't know how long it takes the IRB to give approval. The study I am currently in was delayed for a few weeks and the study nurse said it was a legal issue about the wording in the study contract. I don't know if the patient can contact the IRB. If you try, the worst they can say is that you can't speak with them (might be a conflict of intrest), the best that can happen is that you are putting a face with the study. Knowing that there is someone who is waiting for their decisions might make then work a little faster.

Hivworker's advice about seeing it the study is in another location is excellent. It might allow your Mom to start at an earlier time. Another idea could be to find a study which will allow her to also be on her chemo treatment.

Keep an open line of communication with her study nurse and doctors. They can advocate for your Mom. Hang in there. I understand the anxious feelings of wanting to start right away.

Christine