Clinical trial: NCT03363659
Section: Confidentiality
Subsections: Will My Records Be Kept Confidential?|Information About Confidentiality And Hipaa Authorization|How Will My Information Be Kept Confidential?

Your study records will be kept as confidential as possible. You can find out more in the section "Information about Confidentiality and HIPAA Authorization."
What if there is new information about this study?  
If we learn any new information about this study that might make you change your mind about participating, we will tell you.  
If you want to know the results of the study once it is over, you can ask the investigator.

Note: In this authorization document, "you" and "your data" refer to the subject. If you are a parent or guardian, please remember that "you" refers to the study subject.  
Federal law provides additional protections of your medical records and related health information. That law is the *Health Insurance Portability and Accountability Act* (HIPAA). This study's HIPAA statement is provided below. You are providing your authorization if you sign this form and the accompanying consent or permission form to participate in the study.  
| Who will see my protected health information? Who may have access to my information:                                                                                   | Purpose:                                                        |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Any sponsor, including future sponsors, of the  study and anyone working on behalf of a  sponsor or future sponsor                                                     | To oversee the study and make sure the  information is correct. |
| Advocate Aurora Health consultants and                                                                                                                                 | To protect the rights and safety of subjects and                |
| employees, including IRB members.                                                                                                                                      | make sure the study information is correct.                     |
| Organizations that regulate research (such as  the FDA, Office for Human Research  Protections (OHRP), or similar government  agencies in the US and other countries). | To make sure applicable laws are being  followed.               |
| Organizations that grant accreditation to                                                                                                                              | For Advocate Aurora Health to remain                            |
| hospitals and research programs.                                                                                                                                       | accredited.                                                     |  
By signing this form, you are authorizing access to and sharing of personally identifiable health information. This includes direct access to your medical records at Advocate Aurora Health.  
Please note that the study doctor or study staff may also share personal information about you if required by law (for example, if the study doctor or study staff suspects that you are going to harm someone or yourself; reporting of communicable disease (HIV, hepatitis, tuberculosis, etc.). If you have questions about this, please ask the study doctor.  
How will my information be used for this study? This section explains who will use and share your health information if you agree to be in this study. You must authorize this use and sharing of your information by signing this form or you cannot be in the study.  
The study principal investigator and study staff will collect, use, and share identifiable health information about you for the following reasons:
- to conduct this research study;
- to review the study, and to check the safety and results of the study; INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE **IN A RESEARCH STUDY**  
  
(Consent - **Research)** Page 10 of 14  
| Aurora IRB Stamp of Review   | Complete or apply a patient label   |                  |
|------------------------------|-------------------------------------|------------------|
| Aurora IRB #:                | 17-56                               |                  |
| Version date:                | 03/22/2021                          | Medical Record # |  
- to seek government approval of an investigational study drug, vaccine, device or product if such was involved in the trial;
- to assist a public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, and conducting public health surveillance, investigations, or interventions.  
Information used and shared may include:
- information from your medical records related to the research or your routine medical care;
- information collected about you during the research and any follow-up related to study visits, tests, procedures, outcomes, etc.  
The collected information may contain your name, address, telephone number, health plan number, date of birth, medical record numbers, dates relating to various medical procedures, and/or other identifying information.

We will keep your personal health information as confidential as possible. Your identity will be protected as required by law and according to any policies described in the study consent form you were given. Researchers may share your information with representatives and agents of the sponsor(s) for the purposes of managing and overseeing the study. Usually the health information sent to sponsors does not directly identify participants (for example, by name or address). Instead initials and a code number are used. Some personal information, such as date of birth, will usually be included but will not be used to identify you.  
Once your information leaves Advocate Aurora Health we cannot control how it is used, and the law may not require outside organizations to protect the privacy of your information.  
To maintain the integrity of this research, you might not have access to any health information developed as part of this study until it is completed. At that point, you generally will have access to your health information.  
If this study is designed so that you are intentionally not told what treatment or study intervention you are receiving (called a blinded study), you will not have access to health information in your medical record that was collected as part of this study until those who run the study determine it is no longer necessary to keep you blinded. This usually occurs after everyone in the study has completed study treatment or intervention but can sometimes last until all study data is collected and analyzed.
Clinical trial: NCT03363659
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Are There Any Risks To Me?|Risks Of Disulfiram|Risks Of Copper Gluconate|Reproductive Risks:|Are There Any Benefits To Me?

There may be risks, side effects and discomforts if you choose to participate in this study. These can be physical, emotional, financial or social. The ones we know about are listed below.  
There may be side effects from the study medication, disulfiram. Many side effects go away, but sometimes they can be serious, long-lasting, or may never go away. There may be other side effects that we don't know about yet, so be sure to tell the investigator about any unusual symptoms.

| Common   | Rare but serious                                                      |    |                                                                                                 |
|----------|-----------------------------------------------------------------------|----|-------------------------------------------------------------------------------------------------|
| -        | Drowsiness;                                                           |    |                                                                                                 |
| -        | Feeling tired;                                                        |    |                                                                                                 |
| -        | Headache;                                                             |    |                                                                                                 |
| -        | Metallic or garlic-like taste in the mouth;                           |    |                                                                                                 |
| -        | Skin rash or acne                                                     |    |                                                                                                 |
| -        | Decreased sexual function in men; and                                 |    |                                                                                                 |
| -        | Swollen or sore tongue                                                | -  | An allergic reaction (swelling of lips, shortness  of breath, closing of the throat, or hives); |
| -        | Extreme tiredness;                                                    |    |                                                                                                 |
| -        | Darkening of your urine;                                              |    |                                                                                                 |
| -        | Yellowing of the skin or eyes;                                        |    |                                                                                                 |
| -        | Vision changes;                                                       |    |                                                                                                 |
| -        | Numbness or tingling of arms and legs;                                |    |                                                                                                 |
| -        | Muscle weakness;                                                      |    |                                                                                                 |
| -        | Mental mood changes, like feeling agitated,  excited or confused; and |    |                                                                                                 |
| -        | Seizures                                                              |    |                                                                                                 |  
| Aurora IRB Stamp of Review   | Complete or apply a patient label   |                  |
|------------------------------|-------------------------------------|------------------|
| Aurora IRB #:                | 17-56                               |                  |
| Version date:                | 03/22/2021                          | Medical Record # |  
Disulfiram blocks the processing of alcohol in the body and causes unpleasant effects. You should not consume any alcoholic beverages while taking the study medication. Disulfiram should not be used with any alcohol-containing products such as cough or cold medications.  
Disulfiram can increase the side effects of caffeine. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate.  
Before using disulfiram, tell your doctor or pharmacist of any prescription and nonprescription/herbal products you may be using. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Taken at the dosage used in this research study the nutritional supplement copper has not been reported to cause any side effects. Side effects from taking too much copper may include breathing problems, chest pain, stomach upset, and rash or hives.

Women of childbearing potential will have pregnancy testing prior to starting treatment. You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study.  
If you are sexually active, you should use a barrier method of contraception (such as condoms or diaphragm) during the trial. For women, this should continue for at least 6 months after the last dose of drug to ensure that the drug has cleared the body. For men, contraception should continue for 6 months after the last dose of drug, to ensure that all sperm present in the body during the clinical trial have been replaced.  
For more information about risks and side effects, ask your study doctor.

You may or may not benefit from being in this study. The combination of disulfiram and copper may improve your brain tumor's response to treatment with Temodar, but this cannot be guaranteed.  
It is also possible that your condition could stay the same or even get worse. We hope the information learned will help other patients with glioblastoma in the future.
Clinical trial: NCT03363659
Section: Procedures
Subsections: What Is Involved?|What Will Happen At Each Study Visit?

As a subject, you will be responsible for:
- attending all study visits;
- telling the investigator if you are feeling bad or worse than before; - telling the investigator if you have any changes in medications during the study; and,
- following the directions of the investigator and research team.  
If you agree to take part in this study, you will sign this consent form before any study-related procedures are performed. The investigator and research team will ask you questions and perform tests to see if you qualify to be in the study. The following tests and procedures are part of regular medical care of patients with glioblastoma. This means you will have these whether you choose to be in this study or not.  
- Medical and medication history;
- Physical examination, including a neurological examination which is a series of simple questions and tests that provide important information about the nervous system;
- ECOG Performance Status (ECOG PS) which measures changes in your ability to function; INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE **IN A RESEARCH STUDY**  
  
  
(Consent - **Research)** Page 2 of 14  
| Aurora IRB Stamp of Review   | Complete or apply a patient label   |                  |
|------------------------------|-------------------------------------|------------------|
| Aurora IRB #:                | 17-56                               |                  |
| Version date:                | 03/22/2021                          | Medical Record # |  
- Laboratory blood tests to measure blood counts, your body's metabolism, the function of your kidney and liver, and, if applicable, pregnancy testing;
- Blood tests to monitor the level of copper in your body. Blood for this test will be drawn at the same time as blood for other blood tests done to for your regular medical care; specifically at Baseline, cycle 1 day 1 and cycle 4 day 1.  
- A brain MRI (magnetic resonance imaging), a test that uses powerful magnets and radio waves to create pictures of the brain;
- Surgery to remove as much of your brain tumor as possible;
- Radiation therapy to slow the grown of any remaining tumor that could not be removed during surgery;
- Taking the drug Temodar; and,
- Taking the drug, disulfiram. The medication will be taken twice each day, in the morning and in the evening. Disulfiram is not FDA approved for this indication.  
The following tests and procedures are for research purposes only. This means you will only have these if you agree to be in the study:
- Taking the nutritional supplement copper at the same time that you take the medication disulfiram
- Completion of a medication diary every day to record your taking of Temodar, disulfiram and copper; and
- Completion of a brief quality of life questionnaire that will ask questions about how you are feeling physically, including if you are experiencing any pain, nausea, or feeling tired, and how you are doing emotionally, such as if you are feeling anxious or depressed. It will take you about 5 minutes to complete the questionnaire each time you are asked to do so. You may skip answering any question that makes you feel uncomfortable.  
| Visit                                                                                                    | During this visit the following tests or                                                                                                                                                                                                                                                                                                                                                     | How long   | Reminders   |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------|
| procedures will be performed:                                                                            | is this visit?                                                                                                                                                                                                                                                                                                                                                                               |            |             |
| Visit 1 (At your  first  Multidisciplinary  Clinic [MDC] visit  following surgery for your brain  tumor) | - Provide consent to be part of this research  study; - Medical and medication history; - Physical and neurological examination; - ECOG Performance Status (ECOG PS); - Completion of the quality of life  questionnaire; - Assessment about current use of corticosteroids (medications used to provide relief for inflamed areas of the  body); - Laboratory blood tests; and - Brain MRI. | 4 hours    | None        |
| INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY (Consent - Research) Page 3 of 14    |                                                                                                                                                                                                                                                                                                                                                                                              |            |             |

| Aurora IRB Stamp of Review                                             | Complete or apply a patient label                                                                                                                                                                                                            |                  |           |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------|
| Aurora IRB #:                                                          | 17-56                                                                                                                                                                                                                                        |                  |           |
| Version date:                                                          | 03/22/2021                                                                                                                                                                                                                                   | Medical Record # |           |
| Visit                                                                  | During this visit the following tests or                                                                                                                                                                                                     | How long         | Reminders |
| procedures will be performed:                                          | is this visit?                                                                                                                                                                                                                               |                  |           |
| At the start of  your 4th week of  radiation  treatment                | - Completion of the quality of life  questionnaire - Assessment about current use of corticosteroids; and, - Assessment of any bad effects you may  have experienced from taking the study  medication.                                      | 5 minutes        | None      |
| About every four                                                       | - Physical and neurological examination;                                                                                                                                                                                                     |                  |           |
| (4) weeks                                                              | - ECOG PS; - Laboratory blood tests; - Completion of the quality of life  questionnaire - Assessment about current use of corticosteroids; and, - Assessment of any bad effects you may  have experienced from taking the study  medication. | 1 hour           | None      |
| About every eight                                                      | - Brain MRI                                                                                                                                                                                                                                  | 2 hours          | None      |
| (8) weeks At the time you  stop taking disulfiram and  copper          | - Physical and neurological examination; - ECOG PS; - Completion of the quality of life  questionnaire - Assessment of any bad effects you may  have experienced from taking the study  medication; and, - Brain MRI                         | I hour           | None      |
| About thirty (30)  days after you  stop taking  disulfiram and  copper | - Return for a visit with the study doctor  to determine if you experienced any bad  effects from taking the study medication.                                                                                                               | 1 hour           | None      |  
At the same time you begin receiving radiation therapy and Temodar as part of the standard treatment for your brain tumor, you will also begin taking one-half of an disulfiram tablet (125mg) two times each day with meals. You will take one tablet/capsule of copper (2mg) at the same time you take the dose of disulfiram.  
Aurora IRB #: 17-56 Version date: 03/22/2021 Medical Record #  
If you experience any stomach upset taking the disulfiram and copper together, you may take the copper tablet/capsule 30 minutes after your dose of disulfiram. If you forget to take the disulfiram/copper you should wait until your next scheduled dose.  
You will be asked to bring your completed medication diary and any unused disulfiram and copper to each study visit.  
Temodar is usually given to patients as a capsule that is taken by mouth at home. If you are unable to take Temodar by mouth, or if your insurance will not cover the costs of oral Temodar, you may be asked to come to the clinic daily for intravenous (IV) infusions of Temodar. An IV infusion is a method of delivering a medication directly into a vein through a needle inserted in your arm. Your decision to take part in this study will not influence the decision about you receiving Temodar by IV infusion. Your study doctor will discuss this with you and explain what you will need to do if you receive Temodar as an IV infusion.  
After you stop the study your study doctor will recommend any follow-up based on how you're doing. At approximately two years after stopping the study your study doctor will review your medical record to check on the general state of your health and to see if your cancer has come back.
Clinical trial: NCT03363659
Section: Purpose of Research
Subsections: Why Am I Being Asked To Participate?|What Is The Purpose Of This Study?

You are being asked whether you would like to voluntarily participate in a research study for patients diagnosed with glioblastoma. You are eligible to participate in this study because your tumor has unmethylated MGMT. MGMT is an enzyme that repairs the damage to DNA. When MGMT is unmethylated, it is active and counteracts the effect of temozolomide (also known by the trade name Temodar), the standard chemotherapy treatment for patients with glioblastoma. Research in animal models of glioblastoma and in patients has shown that the combination of disulfiram and copper taken orally will inactivate MGMT, allowing Temodar to work better. Disulfiram (also known by the trade name Antabuse) has been used for decades as a treatment for alcoholism. It is approved by the U.S.  
Food and Drug Administration (FDA) and has a long track record of safety. It is not an experimental medication. Copper is a common nutritional supplement. This clinical study will use well established agents for a different purpose: to inhibit MGMT inside glioblastoma cells so that Temodar can work better.  
This form describes the study and how you can volunteer to participate. We will answer any questions you may have so that you can make an informed decision.

In this study, we want to find out if adding a drug called disulfiram and the nutritional supplement copper gluconate ("copper") improves how unmethylated glioblastoma responds to treatment with Temodar.  
Disulfiram/Antabuse is approved by the FDA for the treatment of people with problem drinking; however, it is not approved for the treatment of patients with glioblastoma.
Clinical trial: NCT03363659
Section: Voluntary Participation
Subsections: Do I Have To Be In This Study?

You do not have to be in this study. If you start the study, you may stop at any time. There is no penalty or loss of benefits if you don't want to participate, and your decision won't affect your regular medical care.  
You may decide to participate now, but change your mind and withdraw from the study anytime without penalty or loss of benefits. If you decide to withdraw before the last study visit, let the investigator know. There may be special procedures to follow for your safety. You may be eligible to receive disulfiram and copper as part of your regular medical care without participating in this research study. You study doctor will be able to answer any question you have about this option.  
INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE **IN A RESEARCH STUDY**  
  
(Consent - **Research)** Page 7 of 14  
| Aurora IRB Stamp of Review   | Complete or apply a patient label   |                  |
|------------------------------|-------------------------------------|------------------|
| Aurora IRB #:                | 17-56                               |                  |
| Version date:                | 03/22/2021                          | Medical Record # |  
If you don't want to be in this study, your other options include:
- Getting treatment or care for your brain tumor without being in a study, including receiving the standard of care treatment of radiation therapy and Temodar;
- Taking part in another study, if one is available;
- 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; or
- Getting no treatment at this time.  
Your doctor can tell you about all your options, and their risks and benefits, before you decide if you will take part in this study.
Clinical trial: NCT03363659
Section: Withdrawal from Study
Subsections: What If I Am Harmed From Being In The Study?|How Do I Cancel My Authorization?

If you get hurt or sick from being in this study, you should seek medical treatment as needed. Be sure to tell the investigator as soon as possible. You will not have to pay for medical treatment of any illness or injury that is caused by your participation in this study. There is no plan to pay for lost income or any non-medical costs that might result from the illness or injury.

You can cancel your authorization to use and share your information at any time by writing a letter to the study doctor. If you cancel your authorization, you will not be able to continue in the study. If some aspects of the study were optional, you may cancel your authorization for the optional part(s) of the