Phase 1 trial is they don’t know what the results are going to be. They don’t know what side effects you’re going to have. They don’t know how well it’s going to work, whether it’s going to work. It’s got to be started somewhere, and [sighs] if, if the phase 1 trial does work on some, they might be able to adjust it to do a different, using the same drugs used in a different way. I actually found out this morning that the dacarbazine could actually be given in tablet form as well, which I didn’t know. But it’s very, very expensive in tablet form, so obviously money does, money obviously comes into it, so that’s why it’s done as a intravenous one. But [sighs] you know, we’ve got to start somewhere and you can only do so much on animals. You don’t ever know what’s, what the human body’s going to do. You know, I look back, when I knew it was a phase 1, and thought of the four chaps that almost died, which was a phase 1 trial*, and thought, “No, you know, it’s closely monitored, very closely.” Because the first two treatments they were taking blood tests every fifteen minutes. It was lots of blood tests so that’s why you were in all day, but very, very closely monitored. And you know, I have been closely monitored. Each time I come there’s ECGs, blood pressure, temperature, urine samples, blood tests.

 

*FOOTNOTE: Anthea is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when several healthy volunteers became extremely ill. Early phase studies are carried out precisely because we need to find out about possible risks and side effects before giving the treatment more widely.

If there was any chance of stopping the disease, or halting it for any length of time, I would give, I would want to give myself that chance. If I said, “No, I don’t want to. I don’t want to do this”, I think I could have had regrets, saying, “Well, if I’d have done that, perhaps I would have still been here.” You know, once you start getting ill, “Well, if I’d have done that, perhaps I’d have stood a better chance. Perhaps it would have slowed down the disease.” And there would have been lots of ‘what ifs’. I’m not into ‘what ifs’. I want to be positive, and I think anybody that knows me will say that I am a very positive person. I’ve had lots of knocks. I’ve had lots of things that I could have said, “Well, why me?” But you pick yourself up, and you’ve got to look to the future. You, you can’t, you can’t look and think, “Well, why did that happen?” These things, things happen in life. “Why me?” I’ve done that. “Why me?” But when I’m feeling, if I’m feeling down then yes I do, do think, “Why?” You know, “Why is it me? What have I done wrong to deserve this when there’s so much going on in this world that it could be somebody else?” But [sighs] when I think logically and positively, then I think, “Well, yes, it’s got to happen to somebody. It’s happened to me. I’ve got to get on with it.” I want to do lots more things in this life and if I’m to do those then I’ve got to take the chance of these trials.

 

Yes.

 

 

Plus the fact it might help - if it doesn’t help me, it might be something that will help somebody else, and if it helps somebody else to save them going through the trauma that I’ve been through, then I’m, I’m happy to do it. If it, if it helps anybody, you know - it might be it might be a friend, it might be a relation, it might be somebody I don’t, don’t ever have contact with or know, or know that it’s helped them - but if I’ve done this and it does help somebody, then all well and good. There’s a purpose to it. 

Within eleven months of that operation I found another lump, which again they removed and did a, did some more dissection, took more lymph nodes. And they sent me again to see the consultant, and they decided then that it was faster-growing than they had anticipated. They did CT scans and it was suggested that I went on the interferon trial. That trial was you’re either - we all had four weeks of intravenous interferon, and then some of us went on for another forty-eight weeks to have three, three injections a week, which were self-administered. And we were checked every three weeks to make sure that everything was going all right. And I managed to do a full twelve months, with some side effects - feeling very tired, flu-like symptoms nearly the whole way through, but I did still manage to work. I cut my hours down. I did four days a week instead of five, but I still managed to work.

 

And they thought that had, that was, things were going well. And then I was clear, that was 2005 I had the interferon. Then in 2007, in the September, I found another lump. And they did a CT scan and they decided that the disease had spread. So they needed to do something about it, but there was no, no set medication. I was offered a trial, and I had two treatments of that trial, and I lost all my hair on that trial, had a wig. I was devastated about losing the hair, but I had a wig and most people said it looked quite normal. So that wasn’t too bad.

 

But then found after another CT scan that it wasn’t actually working because there were five lesions, and it had shrunk, started to shrink one but none of the others were shrinking. So they decided that it wasn’t worth carrying on. So I was then told, “Well, that trial’s not working.” And that is the only time that I felt really let down, because the doctor told me didn’t explain that, “Well, that one’s not working but we can try something else.” It wasn’t until I was told, “That one’s not working.” And I sat there and thought, “Where do I go from here?” And I had to ask the question, “Well, is there anything else?” And it wasn’t until I asked that question that, “Well, yes, there might be other trials, but you have to have a break.”

FOOTNOTE: Anthea has been in three trials. Here she is talking about the first two, a 12-month randomised trial of interferon, followed by a non-randomised trial of paclitaxel (Taxol).

They were very specific saying that, “It is a trial. It’s early days. We haven’t got any results”, that a lot of the tests that went along through the process of the trial had been changed, and, and a lot of the blood tests were made more regularly, because it had been trialled in the States and they’d had one person die on the trial through kidney failure because they hadn’t been monitored, they hadn’t monitored the effect as much. So I knew that, and they had, they had made more blood tests available so so they could, they did monitor you very, very carefully, and have been, in all the trials, I’ve been monitored very, very carefully.

 

And that I think that they have been very, very honest. The doctors have been very honest. You know, that “This, this is a trial. We haven’t got any definite results. It has worked on some people but we’ve, we haven’t got a percentage of who it works on,” [sighs]. And I was told that the chances of the Taxol one working that it was a fourteen per cent chance that that would work. And my attitude was, “Well, somebody’s got to be in that fourteen per cent.” I wasn’t in that fourteen per cent. That one didn’t work. But I wasn’t given any percentages on this one, because it is a phase one trial and I was only number twenty-six. So I knew that it was a very, very sort of new trial, and I was prepared to take that risk.

And I, I also knew about the randomisation, that if I fell in one category I would just have the four weeks of intravenous interferon, but if I fell in the other category that it would be four weeks and then another forty eight weeks. But depending on how the side effects, I could pull out at any time. That’s always been stressed.

 

If you - it is a trial. If you want to say, “That’s it. I’ve had enough”, then that’s fine. And that didn’t happen to me until about four weeks before the end of the trial, I came for an appointment and I said, “I’m feeling really, really tired.” And I wasn’t quite certain how many more weeks I’d got to go, and they said, “Well, you can stop it now if you want to. You’ve only got four weeks to go.” I said, “I’ve this done this far. I’ve don’t this long. I’m quite prepared to do another four weeks.” And the doctor said to me, he said, “Well, you’ve had flu-like symptoms for a year, so it’s not surprising that you’re feeling, beginning to feel low.” So…

 

 

A lot of people had dropped out. They, they just couldn’t take the side effects. And I know of some other people, I actually know of two other people that started on interferon and they, they just couldn’t take it. Even they couldn’t take the four weeks of intravenous. I was ill after the two weeks, and they had to stop for a week and reduce the dosage then. But the consultant said to me, “We like” - quite bizarre, really - he said, “Ah, I’m glad you’re getting these side effects”, he said, “because we know we’ve given you enough.” He said, “Now we can halve them.” And once I’d halved them I was, I was okay and then they started and I got through the four weeks so.

 

I was hoping that I was going to be one of the ones that went for the year. It might sound bizarre, but I thought, “If I’ve got a chance, then that might be the chance that I’ve got. If it, if I go for the year and it’s successful, I’ve done it.” And if I’d only had the four weeks and the, it had reappeared again, then I might have thought, “Well, if I’d have gone for the whole, if I’d have been one of the ones for the year, perhaps it wouldn’t have happened.” But I did the whole year, and I said when the next lump appeared, I said, “Well, interferon didn’t really work.” And they said to me, “But it’s given you two years. It given you the year you were on it and the year after. You’ve had two years.” So in lots of ways I was lucky.

 

FOOTNOTE: Anthea has been in three trials. Here she is talking about the first, a 12-month randomised trial of interferon. 

The drug company did compensate when because the first two sessions I had to come weekly, and I had to be in the whole of one day. And then the second treatment was, was slightly different to the first treatment and I had to be in overnight, or go home and come back early the next morning, which is what I did. But the drug company actually paid our petrol money just for the first sort of two trials. But even if they hadn’t, I’d have still have done it. It, you know, it wouldn’t have made that much difference. It’s petrol money. It’s nothing if, if something’s going to work. 

 

As a person I would like more. I would like more information on the results. Perhaps that’s the type of person I am. I like to know results. Like I said earlier, I worked in research, and the results to me are quite important. Some people wouldn’t want to know the results. My husband’s one of these people that, you know, “Okay that’s what you’re going to do, so carry on and do it.” I’m a bit like a dog with a bone really [laughs]. I like to, I like to know how things are working, and I do ask, I do ask those questions. My husband sort of says to me, “You always want to know the ins and outs of everything.” I said, “Well, it’s my body. I’d like to know where we go from here. I like, I’d like to know what the results are.” And they’ve been, especially on this trial, they have been very, very good, and I know that I am the only one that has gone more than six weeks. So…

 

They are very open about this trial.

 

 

They are giving me feedback because I, because I’m asking. I think if you’re not asking, then perhaps you wouldn’t be getting that information.  

And anybody who’s thinking of going on a trial, ask questions. If you’re uncertain in your own mind that, “No, I don’t think I want to do this” or, “This isn’t for me”, then say so, because it at the end of the day it’s your life. It’s entirely up to you. And if you don’t think it’s right and if it’s not right for the family, then don’t do it. If it’s going to make you unhappy, don’t do it. If it’s going to really worry you that, “This is a trial and I don’t know the results”, then I would say, don’t do it.