[ Inglese] How a Clinical Trial Could Save Your Life

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Topics include: Patient Stories , Treatments and Understanding

When we hear the phrase “clinical trial” we think of an experiment, which is why many of us might not seek those out as options for treatment. Pam Griffith, a lung cancer patient, now in remission, discusses how her cancer was rapidly spreading. With each appointment, her cancer seemed to become more and more progressive. It spread to her bones, her shoulders, and created lesions on her head. She was told there was not much hope of curing the cancer. After her husband talked with Dr. Antonia, he requested to see Pam immediately. He introduced her to a clinical trial that shrunk cancer cells enough to put her into remission.

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Transcript

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:

I want Tony and Pam to just come up and sit over here. Why? Because you’ve been in clinical trials. And just grab one of those microphones. Sit next to the docs.

So I’ll just tell you a little bit of my story for a second. Leukemia, for me, diagnosed in 1996. By connecting with other patients, this sort of thing, people sharing information, I was connected with a specialist like these guys in what I had. And I learned about a clinical trial. And I believe it saved my life.  That’s why I’m here because I was in a clinical trial.  And it happened to be, and we’ll hear about the phases, a Phase II trial. And at that point, it was pretty early.

And those medicines that I received that I believe saved my life, I received them 10 years before they were approved, before the Phase III trial or worldwide trials. That was just my story. The other thing I’d say about clinical trials is I developed a second cancer about four years ago. And I wasn’t in a trial for cancer. It was for a deep vein thrombosis, maybe a blood clot in the leg that I had developed. And when they were monitoring me head to toe like they do in a clinical trial, they found that I had developed a second cancer.

And they picked it up really early. And I take a miracle medicine for the cancer that I have, and it allows me to live a normal life.  And I don’t play golf. But if I did, I could be playing golf. So the point of this is we’re going to make a pitch here for clinical trials. We want you to understand them because, if this field of lung cancer is changing, you might want to consider it tied in with leading experts like this. So first of all, David, what is a clinical trial?

Dr. Carbone:      

Well, a clinical trial is the way we find out about new therapies and prove that they’re better than the old therapies.  And a lot of people think, initially, when we discuss clinical trials, oh, I’m being experimented on.  But the fact is clinical trials now, especially in the United States, are incredibly closely monitored so that I fully believe that clinical trials represent the best care available and possibly a new therapy that’s better.

So, for example, we saw all the people raising their hands in this audience that are on the nivolumab (OPDIVO®) treatment long before it was approved would never have been able to get that treatment if they hadn’t participated in the clinical trial.  

Andrew Schorr:                  

And there are trials to deal with side effects, medicines, those medicines to go through trials as well.

Dr. Carbone:       

Absolutely.

Andrew Schorr:                  

Okay. So what are the phases of a clinical trial?

I used this term Phase II. I know there’s Phase I, and there’s Phase III.  So what does that mean?  

Dr. Antonia:        

So Phase I is the earliest phase.  And the primary goal of a Phase I trial is to be certain that it’s safe. So oftentimes, a low dose is first tested because you don’t know if it’s going to work, because it’s never been tested in anybody before. So you don’t know its efficacy. You don’t know its toxicity. 

So the ethical thing to do is start with low doses. And then that treats cohorts of patients. And then we escalate the dose of the drug. And as each cohort of patients we find that it’s tolerable, we move to the next one. So that’s Phase I.  Phase II, then you focus on more homogenous population of people, a more uniformed stage and type of cancer built into the clinical trial with efficacy as the primary end point.

How often? What is the percentage of the time that people get shrinkage of their cancer? Which really is just a surrogate for how you do.  None of you in this room would care if your tumor shrank if you didn’t live any longer. All you care about is am I alive or not?  And so that is the gold standard.  Are these patients alive or not for long periods of time? What is their survival?  And we learn that in Phase III trials where there is an arm where people get standard of care.

They get no less than standard of care by participating in these trials. Or they may get the new treatment and asked the question is the new treatment making people live longer or not? Because that’s what you all care about. And if that happens, then the FDA pays attention to that, and they say we can approve this drug.

It can be then given to everybody, commercially available and given to everybody. 

Dr. Carbone:       

So I’d like to amplify on two things and especially clarify for patients and family members.  While Phase I trials, the statistical endpoint is safety, the fact is that, in order to get to a Phase I trial, we have to really think that this drug is going to be interesting and good and help patients.

And so even in a Phase I trial, my goal in a Phase I is to find new drugs that help people not figure out a safe dose, etc. so the ultimate goal that’s behind even a Phase I trial is patient benefit. But in addition, now, we’re getting so smart, in some respects, about these new drugs that we can prove efficacy, even in a Phase II trial or even sometimes in Phase I trials.

If we hit the target on the mark with these drugs, and we’re right, our laboratory experiments are right, we can see benefit in 18 out of 20 patients on a Phase I trial. And that could lead directly to fast-track approvals and getting it out into patients. So the lines between these phases are a little blurred now. Whereas before, we would do 10,000 patient Phase III trials to look for a two-week difference in survival.

Now, if we hit the right target with the right drug, we get people dramatically benefiting in almost every time we use the drug. It doesn’t take 1,000 patient trials to show that.

Andrew Schorr:                  

Okay. So we have two people who have been in trials that had different experiences both with the sort of immunotherapy. So first of all, Pam, you were kind of—well, you feared death. 

Pam Griffith:      

Oh, I was. No question about it.

When I was diagnosed with cancer, originally, it was stage III non-small cell. And I did have the surgery. I had my lower-right lobe of my lung was removed. And I was told that I just needed to go on some chemo and radiation. And this was before I was treated at Moffitt. I was being treated elsewhere for that, which I did.

I went on the chemo and radiation. I was given two chemo drugs at the same time and radiation.  I’d get my radiation in the morning and get my chemo right after that.  The problem is, for me, the type of lung cancer I had, the chemo and radiation was not effective at all. And the entire time that I was taking the chemo and radiation, the cancer was spreading throughout my body.

When I finally came to Moffitt, one of the things I had was a large lesion on the back of my head. And I was originally told at that facility where I was getting treatment that that was just an ingrown hair follicle.  But it wasn’t, folks.  It was lung cancer. And my husband had sent a picture of this lesion to Dr. Antonia who said I really want to see her in my office right away.

Long story short, we went. He did a CAT scan.  I had cancer everywhere in my body. It was in both lungs. I had numerous tumors in both lungs.  It went into the bone of my left shoulder. I never thought I’d play golf again ever. I lost the use of my arm. I also had cancer that had spread to my adrenal glands. 

And that day, when Dr. Antonia looked at the CAT scan, he did say to us, because it looked pretty grim, he said, “We could no longer hope to cure you.”  But then he did mention one thing. I knew I had no options. I didn’t know what was going to happen. But he mentioned that there was a new clinical study drug. And he said, “I’d like to try to get into that program.” And it took a while to get me in, because my blood platelets initially were too low.

Mine were like 52, and they had to be over 100. But that was the only thing that was keeping me from getting into the treatment. And Dr. Antonia said, “I want you to go home, and I want you to walk.” Well, walking, for me, was very difficult, because I had become weak. I had become anemic.  I had lost a tremendous amount of weight for me. And but I did it.  And my husband helped me.

He was my cancer coach.  And I made myself walk. And sometimes, it would be so painful I would just have to sit on the curb, because I was still kind of healing from the surgery.  And also, my breathing capacity was not wonderful either.  I could not walk from our bedroom to the kitchen without having to sit down and rest along the way.  So when I got into this program, the drug I was on was nivolumab.

And I’m still in the clinical trial.  After I would say the third treatment, I had a lump that was sticking out of the side of my neck. And it started to go down. I mean, it was shrinking.  The lesion on the back of my head was shrinking.  I started in the clinical trial on September 13, 2013.

And now, the lesion on the back of my head that completely went away, it fell off.  And now, you can’t even tell that there was ever anything there. My CAT scans, the tumors that were in my lungs, they’re gone. Everything that was on my adrenal glands, they have shrunk down to miniscule.

The cancer that was in the bone of my shoulder, it’s gone.  It is absolutely, there’s no sign of it. I have new bone growth where the cancer was.  So for me, I have to say that the cancer, at one point, was going to take my life for sure. And it was ruling my body. But today, this immunotherapy treatment program has given me back my life.

And I never thought I’d ever see a golf course again. I mean, that’s just a huge bonus. So that’s my story. 

Andrew Schorr:                  

Thank you, Pam. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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Page last updated on April 3, 2017