Phasel clinical trials:

Full text

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Information for people wanting to know more

about early clinical trials in cancer

Northern Ireland Cancer Trials Centre,

Belfast City Hospital

Phase l

clinical trials:

what are they all about?

NORTHERN IRELAND CANCER TRIALS CENTRE

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Introduction

We have written this booklet to explain what a ‘ Ι clinical trial’ is. Clinical trials test new treatments for patients with cancer. Clinical trials that were done in the past have led to today’s standard treatments. It is how we find new and better ways to treat cancer. PhaseΙ trials are part of this. Doctors and nurses often have to talk to you about trials at a stressful time when you may be feeling very ‘down’. This might be because you have just been told about your illness or found out that the cancer has come back or got worse. This booklet gives you more information about the PhaseΙ trial so that you can think about it and discuss it at home in your own time. It gives answers to the questions people ask most often. The focus of this booklet is PhaseΙ trials

involving drugs. If a clinical trial in radiotherapy is an option for you, your Doctor or Research Radiographer will discuss this with you.

At the back of the booklet you will find explanations for some of the medical terms that we use when talking about PhaseΙ trials and cancer care. This is a quick way to look up terms that you are not sure about.

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Northern Ireland Cancer Trials Centre Northern Ireland Cancer Trials Centre

Introduction

We have written this booklet to explain what a ‘Phase l clinical trial’ is. Clinical trials test new treatments for patients with cancer. Clinical trials that were done in the past have led to today’s standard treatments. It is how we find new and better ways to treat cancer. Phase l trials are part of this.

Doctors and nurses often have to talk to you about trials at a stressful time when you may be feeling anxious. This might be because you have just been told about your illness or found out that the cancer has come back or got worse. This booklet gives you more information about the Phase l trial so that you can think about it and discuss it at home in your own time. It gives answers to the questions people ask most often. The focus of this booklet is Phase l trials

involving drugs. If a clinical trial in radiotherapy is an option for you, your Doctor or Research Radiographer will discuss this with you.

At the back of the booklet you will find explanations for some of the medical terms that we use when talking about Phase l trials and cancer care. This is a quick way to look up terms that you are not sure about.

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What is a Phase

I

trial?

Phase l trials involve new drugs, new combinations of drugs, or other therapies being used for the first time to treat patients with cancer. It may also include new techniques in radiotherapy, new devices to deliver therapy or new combinations of drugs and

radiotherapy. Sometimes new drug combinations include drugs that have already been used successfully to treat cancer. The doctor will tell you how many patients have received the drugs already. At this stage we do not know if the treatment will work. The main aims in a Phase l trial are:

1. To find a safe dose that can be used in later clinical

trials of the treatment.

2. To find out if there are any side-effects to the

therapy, and what they are like (this is called the ‘toxicity’ of the therapy).

3. To look for any effect of the therapy on the

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How are Phase

l

trials different from Phase

ll

and Phase

lll

trials? If the results of Phase l trials are promising a

Phase ll trial will happen next, followed by a Phase lll trial. Phase ll trials try to find out more about the new drug’s effect on the cancer. A Phase ll trial aims to

compare the new treatment with the best treatments we have already. At any point, if doctors get information about unacceptable risks to patients, or information that the treatment is not as helpful as expected, the clinical trial is stopped. Other treatment options are then discussed with patients.

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How are new drugs discovered?

Scientists are working all the time to see why cancer cells behave the way they do. Sometimes a breakthrough in understanding cancer can lead to a new way to try to kill cancer cells. Some drugs are discovered this way; other drugs are just found by accident when

examining chemicals found in nature (for example in the rainforests or the sea). There are several research programmes testing many chemicals against cancer cells.

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How are Phase I trials organised?

First of all, a group of between 1 and 6 patients is given the drug in a small dose that is expected to be safe. If none of these patients have any effects, or only mild side-effects, then the next group of patients get a higher dose of treatment. In this way, the dose goes up for each new group of patients, until there are side-effects that make it unsafe to increase the dose further. Alternatively, patients are tested in groups looking at a test for drug activity.

Why am I being considered for a Phase I trial?

Phase l trials may be offered to a small number of people for whom there is no other proven or more established

treatment that may help. It may be that there are other possible treatments but we think the Phase l trial may be worthwhile in your case. Your doctor will discuss any treatments that may help you. If you do not want to take part in the trial, no one will try to make you. We must ask for your written consent before you join the trial. You are free to withdraw from the trial at any time without giving a reason.

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Northern Ireland Cancer Trials Centre

This is what makes someone suitable for a

Phase I trial:

Most importantly you must understand about the trial and be happy to take part in it.

You must be fit enough to have the treatment and you

should not have had any treatment (such as chemotherapy or radiotherapy) within the past 4 to 6 weeks. This gives your body a chance to recover from any previous treatment. We will take into account your general health and any other medical problems or illnesses that you have, or have had. In some trials you may have to have some tests – for example, blood tests, heart monitoring (heart trace) – and the results have to be normal.

What are the benefits of joining a Phase I trial?

We offer Phase l trials to people in the hope that they will receive clinical benefit from taking part. However, we cannot guarantee this, and historically around one in ten people have had a significant benefit in a Phase l trial. There is only a small chance the treatment may benefit you. However, many patients feel that hope is important and are keen to try something new. Other people feel that they would rather not try something which probably will not help their cancer. Your doctor will explain what is already known about how the new drug or drugs may affect your cancer.

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Patients taking part in Phase l trials will usually see medical and nursing staff more often than if they were not in the trial, and tend to see the same staff on each visit to the hospital. Many people like this personal attention and find it supports them. In this way some people feel that their quality of life is improved. Some patients like knowing that they are helping further research into cancer treatments and that they may be helping other patients in the future.

Are there any side-effects or risks in taking

part in a Phase I trial?

Yes, there may be side-effects from the drugs and there may be risks. If drugs are at an early stage of development not all their side-effects are known. We will discuss the expected side-effects with you and put them in the Patient

Information Sheet and Consent Form. You will get a copy of this information. If you take part in the trial we will update you on new information about benefits and side-effects as they become available.

What is it like to be in a Phase I trial?

We will give you a lot of information about the trial, as well as information about your cancer, at a time when you may be feeling very anxious. Understanding what is involved can ease some of your worries. While you are taking part in the trial you will be cared for in the in-patient ward or in the day hospital (Bridgewater Suite). At every stage during the trial there will be a team of staff who will be directly

involved in your care. They are experienced in looking after patients with cancer who are taking part in Phase l trials.

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Northern Ireland Cancer Trials Centre

Team members include:

The consultantis the senior doctor responsible for running the trial, and is responsible for your care while you are taking part in the trial. He or she will explain all aspects of your care and will work closely with the team and other doctors and staff to plan and manage your care throughout the trial.

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The pharmacist can help to explain how and why you are being given your drugs, and can answer any questions you may have about your new drugs or any other medication you may be taking.

The clinical research nurse

will manage the trial and explain what it involves. He or she will work with your doctor in organising any tests or examinations as well as supporting you through your treatment. You can phone and speak to them Monday to Friday (from 9am to 5pm), or they may phone you to see how you are doing. You will be given the name of one or two clinical research nurses who will be looking after you and see you at visits, so you will get to know them well. During the trial you will have to follow a schedule of assessments, treatment and

investigations by the doctor and clinical research nurse. We will take blood tests to see how your body is reacting to the drug. The team will discuss the schedule with you and it will usually mean coming to the clinic at least once a week. It is important that you consider the practicalities of taking part, for example, the travelling, the number of visits, and the time spent away from your family. As you go through the trial we will collect information about you and this will always be confidential.

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Northern Ireland Cancer Trials Centre

Research sampling

This can involve collecting blood, urine or tissue samples to find out more about:

1.What happens to the drug inside your body. 2.The effect the drug has on your body.

You will find out exactly what will be involved in the trial. Most Phase l trials involve some or all of these tests: Blood sampling - a small

plastic tube (called a cannula) will be put into your arm using a needle, and will stay there while you are having your blood sampled that day. All the samples will be taken through this plastic tube, which will be held in place

by a dressing. This means you don’t have to have a needle inserted in your arm every time we need a sample.

Urine sampling - this may involve a ‘dipstick’ urine test or collecting all the urine you pass for one whole day (24 hrs) into a plastic container.

Tissue samples from your tumour may be taken in the theatre, in the clinic or on the ward by a doctor. These different types of samples may be taken on several days during your treatment and may mean staying overnight in hospital. The blood and urine samples will be taken by the clinical research nurse and will usually be stored in a freezer to be studied later.

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What should I do if I become ill while taking

part in a Phase I trial?

If you are feeling unwell following treatment, it is very important that you contact the Belfast City Hospital immediately and speak to staff on the 24 Hour Helpline. They will be able to help you. Make sure that you tell any staff you are talking to about the trial you are involved in. All contact phone numbers are at the back of this booklet.

What protection do I have when taking part in

a Phase I trial?

Each Phase l trial must first be approved by an independent ethics committee. These committees are designed to protect patients and are made up of scientists, doctors, clergy, and other professional and lay people from the local community. An ethics committee reviews a trial to see that it is well designed with safeguards for patients and that the risks are reasonable considering the possible benefits. The protocol (trial plan) is reviewed and the progress of each trial discussed regularly. It is also approved by the Northern Ireland Cancer Clinical Trials Coordinating Committee, by the Hospital Trust and by the Medicines and Healthcare Products Regulatory Agency (a branch of government).

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Northern Ireland Cancer Trials Centre

What is ‘informed consent’?

Informed consent is when you are given information to help you understand what is involved in a trial, including the potential benefits and risks. You then decide freely whether or not you wish to take part. The doctor or clinical research nurse will give you a Patient Information Sheet and Consent Form that describes the trial and the new treatment being tested. You should take your time and read the form carefully. You will be able to take this form home and discuss it with your family, GP and other people before you make your decision.

Don’t be afraid to ask questions until you feel you have all the facts you need to decide. This is an important decision and you should feel at ease with the choice you make.

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What if I say ‘no’ to a Phase I trial?

If you decide that you don’t want to take part in a Phase l trial, you should tell the doctor or clinical research nurse. You do not have to give a reason and your decision will be respected. The doctor will already have discussed

alternatives to the trial, and the standard of care you receive will not be affected by your decision.

What if I say ‘yes’ to a Phase I trial?

If you decide you want to take part in the Phase l trial you should tell the doctor or clinical research nurse. They will ask you to sign the Consent Form and will give you a copy to keep. If you decide at any time that you want to stop taking the drug and no longer want to stay in the trial you can withdraw. You do not have to give a reason and your decision will not be held against you.

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Northern Ireland Cancer Trials Centre

What happens at the end of Phase I trial

treatment?

You will be followed up for around one month after your last treatment, or longer if necessary. Some

investigations and blood tests may be repeated during this time. At this point you may be referred back to your original doctor or stay with the same doctor, who will continue to care for you when you have finished the trial. The clinical research nurse may not see you when you visit again, but you can phone him or her in the future if you want to.

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Pha

Medical terms we have used in this booklet

Cannula - A small plastic tube put into a vein in your

arm using a needle. Blood samples can be taken from the tube.

Chemotherapy - Drug treatment using anticancer

drugs.

Clinical trial - A study to investigate new treatments

for patients.

Clinical Research Nurse - A nurse who has

specialised in clinical trials.

Consultant - A specialist doctor who is responsible for

the diagnosis and treatment of patients in their care.

Heart trace - A test that records the electrical signals

your heart produces, also called an ECG (electrocardiogram).

Patient Information Sheet and Consent Form -

A form which has all the up-to-date information about the trial. You sign it to give your permission to have the treatment described on the form.

Pharmacist - An expert who makes sure that patients

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Northern Ireland Cancer Trials Centre

Pha

Phase

Ι trial

Phase

ΙΙ

ase

ΙΙΙ trial

Phase

ΙΙ trial

Phase l trial - A study to find the best safe dose of a

new treatment and the side - effects the treatment can cause.

Phase ll trial - A study to look at the effect a new

treatment has on a specific disease.

Phase lll trial - A study to compare a promising

treatment with the best treatments we have now.

Protocol - This is the plan that describes which patients

are suitable for a trial and how the trial is run.

Radiotherapy - A treatment for cancer using high

energy beams of radiation.

Research Radiographer - A radiographer who has

specialised in clinical trials.

Side-effect - Any effect of a treatment which is not the

desired beneficial effect.

Tissue sample - Cells that are collected from a

particular part of the body.

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Acknowledgements

Our thanks to the patients who have participated in photographs and helped in the development of this booklet.

Booklet prepared by:

Early Phase Cancer Clinical Trials Team: Oct 2012 We gratefully acknowledge the generous financial support of our funders:

Contact numbers:

Northern Ireland Cancer Trials Centre:

Monday to Friday, 9am to 5pm phone: 028 9026 3903

24 Hour Helpline:

24 hours a day, 7 days a week phone: 028 9026 3805

This leaflet contains general information only.

For information about your own treatment, please talk to your doctor or research nurse.

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