Consent Of An Adult To Be In A Research Study

IRB-HSR # Study title

Consent of an Adult to be in a Research Study

1. Participant’s Name______

2. Medical Record # ______

What is the Purpose of this Form? This form will help you decide if you want to be in the research study. You need to be informed about the study before you can decide if you want to be in it. You should have all your questions answered before you give your permission, or consent, to be in the study. This is called an “informed consent” form because it informs you before you sign to give your consent.

Please read this form carefully. Ask about any part you don’t understand. Then decide if you want to be in this study. If you do want to be in the study, you will need to sign this form to give your consent. You will get your own copy of this signed form for your records.

Introduction You are being asked to be in this study because you have Disease X that has relapsed or has not responded to chemotherapies or other forms of treatment given to you.

This is a study about an investigational drug called Drug 1 that is designed to kill cancer cells and slow the growth of cancer. Investigational means the drug is still being studied and researchers are trying to find out more about it – such as what the safest dose is, what the side effects are, and if the drug is effective for treatment of different types of cancer. It also means that it has not yet been proven to be safe or helpful by the United States Food and Drug Administration (FDA). So far, Drug 1 has been given to over XX people with different kinds of cancers. Most of these people are currently enrolled in ongoing studies.

An additional drug called Drug 2 will be given to you if your cancer does not respond to Drug 1 alone. This drug has been approved by the FDA. Drug 2 is similar to a natural hormone produced by your adrenal glands. It often is used to replace this chemical when your body does not make enough of it. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid and intestinal disorders, severe allergies, and asthma. Drug 2 is also used to treat certain types of cancer.

The purpose of this study is to see if Drug 1 will cause your cancer to improve and to see the types and severity of side effects caused by treatment with this drug.

Up to X people will be in this study at UVa, and about XX people will be in this study at all participating centers throughout the United States.

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Who is paying for this study? This study is being paid for (sponsored) by...

The University of Virginia is being paid by XX to do this study and to give them information we collect from you and about you during the study.

Who should not be in this study? You can NOT be in this study if…  Certain test results show that it is not safe for you to be in the study (tests are listed below under Screening).  You have received any other chemotherapy for Disease X within the last X weeks.  You have a history of allergic reactions to drugs similar to Drug 1.  You have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.  You are pregnant or breast feeding.  You have an infection or other medical condition that would prevent you from taking part in this study.

There may be other exclusions that will be discussed with you. Please be truthful about your medical history. You should not be in this study if you do not meet all the qualifications. Certain conditions may mean it is not safe for you to be in the study.

What will be done if you are in the study? A. Screening

After signing this consent form and before you can start in this study, there will be a screening period. You will have certain tests and procedures during this time to find out if you can be in the study. These tests and procedures are part of standard cancer care and may be done even if you do not join the study. If you have had some of these tests or procedures done recently, they may not have to be repeated. This will be up to your study doctor. These tests and procedures include:  Review of your medical history including medications you have taken or are currently taking  Complete physical exam including measurement of height, weight, and vital signs (temperature, blood pressure, pulse, heart rate, and breathing rate)  Blood tests (X teaspoons) to make sure your liver, kidneys, and bone marrow are okay  Urine sample for routine tests  Evaluation of your ability to perform normal everyday activities  Electrocardiogram (ECG) – a test that measures your heart function  X-rays of your bones to check for Disease X located in any of your bones  Chest x-ray

 Bone marrow samples, which will be collected by having an area of your hip or chest bone numbed with anesthetic and a small amount of bone marrow drawn through a large needle  Pregnancy test if you are capable of having children

If you qualify for this study and decide to participate, you will be enrolled and your study doctor will be able to start your treatment with Drug 1.

B. Treatment Schedule

The treatment period for this study consists of [fill in.] For each cycle, you will take (however many) Drug 1 tablets by mouth with food at bedtime every day. At the end of each cycle, your Disease X will be checked by your doctor. There is no rest period between cycles. This means you will need to take a Drug 1 tablet every day for all X cycles unless you need to stop taking the tablets either temporarily or permanently.

You will have routine exams, tests, and procedures while in this study. During the study treatment, you will need to:  Come to the clinic for a visit once a week for the first cycle. For all future cycles, you will come to the clinic once every X days. At these visits, you will be asked how you have felt since the last visit. You will also need to bring your pills and bottle back with you so that more pills can be dispensed.  Complete a form called patient diary. Your doctor will provide the patient diary so that you can write down information about when you took Drug 1 and any side effects you might have experienced.  Have your ability to perform everyday activities evaluated for as long as you continue to receive Drug 1.  Have a physical exam including measurements of your vital signs (blood pressure, heart rate, temperature, and breathing rate) and weight for as long as you continue to receive Drug 1.  Have blood (X teaspoons) collected for routine tests for as long as you continue to receive Drug 1.  Have urine collected every XX days for as long as you continue to receive Drug 1.  Have x-rays of your bones and/or a sample of bone marrow collected, if your doctor feels it is necessary.

You cannot receive any other treatments for cancer while you are on this study.

After each clinic visit, if your Disease X is not worsening: You will start another cycle of treatment. You will take three Drug 1 tablets by mouth with food at bedtime every day for another XX days. At the end of each cycle, your Disease X will be checked by your study doctor.

If you experience a worsening of your Disease X: Your study doctor will add another drug, Drug 2, to your treatment. You will take Drug 2 by mouth twice a week along with the Drug 1 tablets at bedtime every day for XX days. You

will repeat these cycles for a total of X cycles unless your Disease X continues to get worse. At the end of each cycle, your Disease X will be checked by your doctor. If your Disease X continues to worsen, you will be discontinued permanently from this study.

How long will you be in the study? You may receive up to XX cycles on this study. If you complete the XX cycles, your disease is not worsening on Drug 1, and you do not have intolerable side effects, then you may continue to receive Drug 1 at your study doctor’s discretion.

General information You may receive Drug 1 as long as your Disease X is responding to treatment, you do not have serious side effects, and your study doctor feels it is in your best interest to continue treatment in the study.

If, at any time, your disease gets worse or you experience any serious side effects, you will be taken off the study, and your study doctor will discuss other treatment options with you.

If you complete XX cycles on this study, your disease is not getting worse on Drug 1, and you do not have any serious side effects, you may continue to receive Drug 1 at your study doctor’s discretion.

C. Follow-up

When you stop receiving Drug 1, you will have a follow-up visit to the clinic scheduled. This visit will be within XX weeks of your last dose of study medication and before you start any new therapy. If you decide to withdraw from the study, you will still be asked to return to the hospital clinic within XX weeks of your last dose of Drug 1. This visit is important to make sure there are no residual effects from taking Drug 1. At this follow-up visit, you will:  Have a complete physical exam including measurements of your vital signs (blood pressure, heart rate, temperature, and breathing rate) and weight.  Be asked questions about any medications you have taken since your last dose of the study drug.  Have your ability to perform everyday activities evaluated.  Be asked how you have been feeling since the last visit.  Have blood (around XX teaspoons) and urine collected for routine tests.

Information about your bone marrow aspirate and biopsy:

If you agree to take part in this study, you will have a bone marrow aspirate and biopsy before you start treatment. You will also need to have this procedure repeated if your cancer completely goes away during treatment.

This is a simple, outpatient procedure. You will lie on the exam table, and the skin over the pelvic bony prominence in your back will be numbed with a medicine. The bone marrow needle is then inserted into the bone. The procedure itself only takes about five minutes.

You may experience some discomfort during the process; however, virtually no pain or problems afterwards. With the needle in the bone, two kinds of samples are obtained:

1. Bone marrow aspirate, which uses a syringe with the bone marrow needle and suctions a very small amount of liquid mixed with blood. 2. Bone marrow biopsy, which takes a sample of the pelvic bone itself, using a special bone marrow needle.

If you want to know about the results before the study is done:

During the course of this study, new information about the risks or benefits of study participation may become known to the researchers. If significant new findings develop that might affect your willingness to participate, this information will be reported to you as soon as possible. This new information may mean that you no longer wish to participate or that you can no longer participate in this study. If this occurs, the study leader, PI Name, will stop your participation. In all cases, you will be offered all available care to suit your needs and medical condition.

We cannot tell you any other information until the results have been studied. At that time you can ask for more information.

This study is not meant to find out if you have any other disease or problem.

What are the risks of being in this study? All chemotherapy drugs have side effects, which can be anything from mild and reversible to severe, long-lasting, or possibly life-threatening or fatal. Everyone taking part in this study will be watched carefully for side effects. However, doctors don’t know all the side effects that may occur.

Your study team may give you medicines to help lessen side effects. Many side effects will go away soon after you stop taking the drug(s), but sometimes a new treatment is needed to manage the side effects. Very rarely, patients have had serious side effects after treatment that sometimes required hospital care, transfusions, intravenous therapies, or even resulted in death.

You need to tell your study doctor or a member of the study team immediately if you experience any negative side effects.

Risks and side effects related to Drug 1:

Likely (may occur in 10 or more patients in 100):  Nausea  Vomiting  Diarrhea  A decrease in the way your red blood cells carry oxygen to the rest of your body  Fatigue  Joint pain

 Constipation  Potential changes in the chemical balance of your blood which could affect the functioning of your liver  If you have had gout in the past, it may return. You will be given medication to try and prevent this from happening.

Less likely (may occur in 1 to 9 patients in 100) :  Hiccups  Loss of appetite  Intestinal gas

Rare (may occur in less than 1% of people) :  Cataracts  Shortness of breath  Dehydration

You will be given medications to help control some of the side effects of Drug 1. Your doctor will decide if you can take these medications by mouth or if they should be given through a vein in your arm.

Rarely in animal studies, damage to the retina of the eye occurred. In previous clinical studies, one patient developed cataracts. Your physician may refer you to an eye specialist if any eye symptoms develop.

Risks and side effects related to Drug 2:

Likely (may occur in ten or more patients in 100) :  Increased appetite with weight gain  Sleep disturbance  Salt and fluid retention with swelling of ankles  Increased blood pressure  Congestive heart failure  Increased risk of infection  Bruising of the skin  Mood changes  Delayed wound healing  Depression  Increased blood sugar  Skin rash  Muscle Weakness  Menstruation changes

Less likely (may occur in 1 to 9 patients in 100) :

 Loss of appetite  Muscle twitching  Increased thirst  Frequent urination  Sweating  Diarrhea  Nausea/Vomiting  Headache  Fracture of weak bones and loss of calcium from bones  Increased heart rate  Fungal infections

Rare (may occur in less than 1% of people):  Blurred vision  Personality changes  Stomach ulcer and hemorrhage  Dizziness

Risks of having your blood drawn: Having blood drawn may cause:  pain (common),  a bruise (sometimes),  fainting or passing out (not very often), and  infection (rare)

If the people doing the study are exposed to your blood or body fluids in a way that could give them a disease, your blood may be tested. The tests might check for:  hepatitis,  HIV (Human Immunodeficiency Virus), or  other infections

You and the person exposed would be told the test results. However, your name would be kept private. If your test is positive for hepatitis or HIV, we will tell you how to find counseling. You may want help in understanding what the results mean for you.

Risks of a Bone Marrow Aspirate and Biopsy (to examine bone cells under a microscope)

When bone marrow is collected for testing, you may experience pain, bruising, bleeding, redness, swelling, and/or an infection at the site where the needle was inserted. An allergic reaction to the anesthetic may occur. A scar may form at the site of needle entry.

Drug 1 and Drug 2 pills:

Do not share your pills with anyone. They are prescribed only for you and could hurt someone else. Keep your pills out of reach of children and people not able to read or understand the label.

Pregnancy and Contraception:

Drug 1 may harm an unborn baby. If you are capable of becoming pregnant or making someone pregnant, you must use adequate birth control methods while on this study, and for 3 months following the end of your treatment.

Acceptable methods of birth control include regular use of: 1) hormonal methods such as the pill, Depo Provera injections, an intrauterine device (IUD), the patch (Ortho Evra), or the NuvaRing and/or 2) barrier methods such as a condom with spermicide, diaphragm, cervical cap, cervical shield, or contraceptive sponge.

Please ask your study doctor if you have any questions about acceptable methods of birth control.

Risks for women: You cannot participate in this study if you are pregnant, are trying to become pregnant, or if you are breast feeding. There may be unknown risks to you if you become pregnant during the study. If you are a female and are capable of having children, you will be required to have a pregnancy test within 7 days prior to starting the study.

If you suspect that you have become pregnant while participating in the study, you must contact the study doctor immediately. You may not continue in the study if you become pregnant.

Risks for men: You should not father a baby while you are in this study. Like other cancer treatments, Drug 1 may cause you to be unable to make someone pregnant in the future. You may want to consider storing sperm in a sperm bank before receiving Drug 1.

Other unexpected risks:

You may have side effects that we do not expect or know to watch for now. Please call the study doctor if you have any symptoms or problems.

Because of the side effects and time required for the tests and clinic visits while you are on this study, you may be unable to keep up with normal daily activities such as running errands or going to work.

Could you be helped by being in this study? Taking part in this study may or may not make your health better. Testing that has been done in the laboratory (called preclinical testing) shows that Drug 1 may improve the treatment care of patients with Disease X, but there is no proof of this yet. We do know that the information from this study will help doctors learn more about Drug 1 as a treatment for cancer. This information could help future cancer patients.

What are your other choices if you do not join this study? You do not have to be in this study to be treated for your illness or condition. You can get the usual treatment even if you choose not to be in this study. The usual treatment includes two other cancer fighting drugs, XX and YY, steroids, bone marrow treatment, and radiation.

Your other choices may include:  Taking part in another study  Getting no treatment  Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.

Will you be paid for being in this study? You will not get any money for being in this study. You will also not receive any money for any patents or discoveries that may result from your participation in this research.

Will being in this study cost you any money? You or your insurance company will be responsible for the cost of medications or procedures associated with the routine medical care of your cancer, including any complications of your underlying illness.

The lab tests, x-rays, skeletal survey, ECG, bone marrow samples, potential hospitalizations, clinic visits, and use of medications to control side effects are standard for the treatment for your disease. Some of these procedures may be done at a higher frequency than normal for the purposes of this study. All of these costs will be billed to you or your insurance company with one exception. If you require more than one skeletal survey, the study will pay for the additional survey(s).

Drug 1 will be provided free of charge for this study. However, Drug 2 will not be paid by the study - you or your insurance company will be responsible for that cost.

You will be coming to the study center more often than if you were not part of a study. There may be some extra traveling costs that you will have to pay.

Some health plans will not pay for certain costs for people taking part in studies. You may wish to check with your insurance company before the study starts. Ask what they will cover and if they require you to get their permission before we treat you.

The National Cancer Institute provides an online resource to help people participating in cancer clinical trials understand which services their insurance company is required by law to pay. This can be found at the following website: http://www.cancer.gov/clinicaltrials/learning/insurance- coverage.

What if you are hurt in this study? If you are hurt as a result of being in this study, we have no plans to pay you for lost wages, disability, or discomfort. If you are hurt in the study in a way that is unexpected (meaning in a way that is not listed in the risks part of this form), your insurance company may pay for your treatment. If they do not pay, University of Virginia will treat you free of charge.

If you have questions about what will be covered if you are hurt in the study, talk to the study doctor. You do not give up any legal rights by signing this form.

What happens if you change your mind? You can change your mind about being in the study any time. It is always up to you. You can choose not to join in the first place. Or you can choose to stop during the study. You do not have to be in this study to get services you can normally get at the University of Virginia.

It is important to tell the study doctor if you are thinking about stopping, so any risks from Drug 1 can be evaluated by your doctor. In some cases, the abrupt stopping of a drug can have risks in itself, so it is important to discuss stopping the treatment with the study doctor. Another reason to tell your doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.

If you decide to stop being in the study or are asked to stop, you must answer any questions asked regarding your experience with the study medication. You must return all study related materials such as unused pills and bottles. If you decide to stop being the study, you should contact the research doctor immediately. You may be asked to cooperate in having whatever laboratory tests and physical examination the research doctor feels is necessary. In addition, before taking any other medication you should discuss it with the research doctor. This includes any prescription drugs as well as over-the-counter medications such as cough and cold medicines, pain relievers, and antacids. The use of illegal drugs during this study is strictly prohibited.

Even if you do not change your mind, the study doctor or the sponsor can take you out of the study. This might happen if:  the study doctor is concerned about your health  you do not follow instructions given to you  the study procedures are found to be unsafe or if you experience severe side effects

How will your personal information be shared?

The UVa researchers are asking for your permission to gather, use and share information about you for this study. If you decide not to give your permission, you cannot be in this study, but you can continue to receive regular medical care at UVA.

If you sign this form, we may collect any or all of the following information about you: o Personal information such as name, address, date of birth, social security number o Your medical records and test results from before, during and after the study from any of your doctors or health care providers (including mental health care and substance abuse records, and HIV/AIDS records) o Information needed to bill others for your care

Who will see your private information? o The researchers to make sure they observe the effects of the study and understand its results o People or committees that oversee the study to make sure it is conducted correctly o People who pay for the study, including insurance companies o Tax reporting offices (if you are paid for being in the study) o People who evaluate study results, which can include sponsors that make the drug or device being studied, researchers at other sites conducting the same study, and government agencies that provide oversight such as the Food and Drug Administration (FDA)

The information collected from you might be published in a medical journal. This would be done in a way that protects your privacy. No one will be able to find out from the article that you were in the study.

What if you sign the form but then decide you don't want your private information shared? You can change your mind at any time. Your permission does not end unless you cancel it. To cancel it, please send a letter to the researchers listed on this form. Then you will no longer be in the study. The researchers will still use information about you that was collected before you ended your participation. UVa researchers will do everything possible to protect your privacy. However, they will need to share your information with people who may not have to follow the rules described above. Some of those people may be allowed to share/release your information without your permission.

A copy of this consent form will be put in your medical record. (This is not the same as the record of this research study.) This means that everyone who is allowed to see your records will be able to find out that you are in this study. This is done so your regular doctors will know what drugs or treatment you are getting in the study. If you have other health problems during the study, they will be able to treat you properly.

Contact Information Please contact the people listed below to:  Learn more about the study

 Ask about the way the study is done or about treatments  Report an illness, a research related injury, or other problem (you may also need to tell your regular doctors)  Leave the study before it is finished

Report a concern about the study:

Principal Investigator: Mailing address: Telephone:

You may also report a concern about a study or ask questions about your rights as a research subject by contacting the Institutional Review Board listed below.

University of Virginia Institutional Review Board for Health Sciences Research PO Box 800483 Charlottesville, Virginia 22908 Telephone: 434-924-2620 / Fax: 434-924-2932

When you call or write about a concern, please give as much information as you can. Include the name of the study doctor, the IRB-HSR Number (at the top of this form), and details about the problem. This will help officials look into your concern. When reporting a concern, you do not have to give your name.

Conclusion What does your signature mean? Before you sign this form, please ask questions about any part of this study that is not clear to you. When you sign below, you are saying you understand the information we gave you about the study and in this form. If you sign the form it means that you agree to be in the study.

______PARTICIPANT PARTICIPANT _ (SIGNATURE) (PRINT) DATE

______PERSON OBTAINING CONSENT _ _ (SIGNATURE) PERSON OBTAINING DATE CONSENT (PRINT)

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