Clinical trial: NCT02212574
Section: Alternatives
Subsections: 7. What Are Your Options If You Do Not Want To Be In The Study?

If you do not want to participate in this study, your alternative is to receive the standard therapy for Wntpositive medulloblastoma or to participate in a different research study. Your doctor(s) will discuss these options with you. You do not have to join this study. If you do not join, your care at Johns Hopkins will not be affected.
Clinical trial: NCT02212574
Section: Confidentiality
Subsections: Research Participant Informed Consent And Privacy Authorization Form|12. How Will Your Privacy Be Protected?|D. What Happens To Data And Biospecimens That Are Collected In The Study?|We Will Give You A Copy Of This Signed And Dated Consent Form

Protocol Title: **Pilot Study of a Surgery and Chemotherapy-Only Approach in**
the Upfront Therapy of Children with Wnt Positive Standard Risk Medulloblastoma  
| Risk Medulloblastoma                                                                                                                                                 |                           |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Application No.:                                                                                                                                                     | NA_00091840               |
| Sponsor:                                                                                                                                                             | Matthew Larson Foundation |
| Principal Investigator: Kenneth Cohen, MD, MBA  Johns Hopkins Hospital  Bloomberg 11379  1800 Orleans St.  Baltimore, MD 21287  Phone 410-614-5055  Fax 410-955-0028 |                           |

We have rules to protect information about you. Federal and state laws and the federal medical Privacy Rule also protect your privacy. By signing this form you provide your permission, called your
"authorization," for the use and disclosure of information protected by the Privacy Rule.  
The research team working on the study will collect information about you. This includes things learned from the procedures described in this consent form. They may also collect other information including  
  
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your name, address, date of birth, and information from your medical records ([which may include information about HIV, drug, alcohol or STD treatment, genetic test results, or mental health treatment). The research team will know your identity and that you are in the research study. Other people at Johns Hopkins, particularly your doctors, may also see or give out your information. We make this information available to your doctors for your safety. People outside of Johns Hopkins may need to see or receive your information for this study. Examples include government agencies (such as the Food and Drug Administration), safety monitors, other sites in the study and companies that sponsor the study. If you are in a cancer study that receives federal funding, the National Cancer Institute (NCI) now requires that we report identifiable information (such as, zip code) about your participation. You may contact the NCI if you have questions about how this information is used. We cannot do this study without your authorization to use and give out your information. You do not have to give us this authorization. If you do not, then you may not join this study. We will use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside Johns Hopkins who receive your information may not be covered by this promise or by the federal Privacy Rule. We try to make sure that everyone who needs to see your information keeps it confidential - but we cannot guarantee that your information will not be redisclosed.  
The use and disclosure of your information has no time limit. You may revoke (cancel) your permission to use and disclose your information at any time by notifying the Principal Investigator of this study by phone or in writing. If you contact the Principal Investigator by phone, you must follow-up with a written request that includes the study number and your contact information. The Principal Investigator's name, address, phone and fax information are on page one of this consent form.  
If you do cancel your authorization to use and disclose your information, your part in this study will end and no further information about you will be collected. Your revocation (cancellation) would not affect information already collected in the study, or information we disclosed before you wrote to the Principal Investigator to cancel your authorization.

Johns Hopkins and our research partners work to understand and cure diseases. The biospecimens and/or data you provide are important to this effort.  
  
If you join this study, you should understand that you will not own your biospecimens or data, and should researchers use them to create a new product or idea, you will not benefit financially. With appropriate protections for privacy, Johns Hopkins may share your biospecimens and information with our research sponsors and partners.  
16. **Assent Statement**  
  
This research study has been explained to my child in my presence in language my child can understand. He/she has been encouraged to ask questions about the study now and at any time in the future.

| ________________________________________________________________________________________________________________________  Signature of Parent (Print Name) Date/Time  ________________________________________________________________________________________________________________________  Signature of Person Obtaining Consent (Print Name) Date/Time  ________________________________________________________________________________________________________________________  Signature of Legally Authorized Representative (LAR) (Print Name) Date/Time  For CHILD PARTICIPANT  ________________________________________________________________________________________________________________________  Description of LAR's authority under state or applicable local law to act as surrogate health care Date/Time  decision-maker for child research participant (for example, Legal Guardian, court-ordered representative)  ________________________________________________________________________________________________________________________  Signature of Parent #2 (Print Name) Date/Time  (required if DHHS 45 CFR 46.406 or 46.407/FDA 21 CFR 50.53 or 50.54 study)  ________________________________________________________________________________________________________________________  Signature of Child Participant (optional unless IRB required) (Print Name) Date/Time  ________________________________________________________________________________________________________________________  Signature of Witness to Consent Procedures (Print Name) Date/Time  (optional unless IRB or Sponsor required)  I have received the separate Insurance and Research Participant Financial Responsibility Information Sheet.   |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
___________________________________________________________________________________________________________ Signature of Participant, LAR or Parent/Guardian (Print Name) Date/Time NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; A COPY MUST BE GIVEN
TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE FAXED TO 410-367-7382; IF YOU ARE NOT USING EPIC
A COPY MUST B**E PLACED IN THE PARTICIPANT'S MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR WILL BE CREATED).**
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN THE CONSENT OF RESEARCH
PARTICIPANTS.
Clinical trial: NCT02212574
Section: Duration of Study Involvement
Subsections: For This Research, Standard Chemotherapy Should Begin Within 30 Days From The Time Of Surgery.

There will be 9 cycles of chemotherapy. There are two different kinds of cycles given. They are referred to as A and B.  
Cycle A lasts for 6 weeks and Cycle B lasts for 4 weeks. B cycles are given after the completion of two A cycles. Below are the details of the drugs and schedules for A and B cycles. Cycle A (This cycle lasts 42 days)
x Lomustine (CCNU) is given by mouth on Day 1.  
x Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.  
x Cisplatin is given directly into a vein over 8 hours on Day 1 Cycle B (This cycle lasts 28 days)
x Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2. x MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.  
x Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.  
You may also get a supportive care drug called a myeloid growth factor (filgrastim [G-CSF] or pegfilgrastim). This drug will help your blood counts recover after the chemotherapy is given.
Clinical trial: NCT02212574
Section: Participant's Rights
Subsections: 17. What Does Your Signature On This Consent Form Mean?

Your signature on this form means that: You understand the information given to you in this form; you accept the provisions in the form and you agree to join the study. You will not give up any legal rights by signing this consent form.
Clinical trial: NCT02212574
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 4. What Are The Risks Or Discomforts Of The Study?|5. Are There Risks Related To Pregnancy?|6. Are There Benefits To Being In The Study?|14. What Treatment Costs Will Be Paid If You Are Injured In This Study?|C. What Should You Do If You Are Injured Or Ill As A Result Of Being In This Study?|What Are The Risks Or Discomforts Of The Standard Chemotherapy?

The major risk of this study is that by not giving the radiation treatment, your tumor will come back. If this happens, more treatment could be given including more surgery, radiation therapy and more chemotherapy. However, it is possible that despite given more treatment if the tumor comes back, your doctors will not be able to treat the tumor and you would die of your disease or a complication of this treatment. Information about the risks of the standard chemotherapy are included at the end of this consent form. These risks would be the same whether you agree to participate in this study or not.

Women should not become pregnant and men should not father a baby while on this study because the drug(s) in this study can be bad for an embryo or fetus. If you or your partner can get pregnant, it is important for you to use birth control or not have sex 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 birth control methods might not be approved for use in this study. Women should not breastfeed a baby while on this study. Also check with your doctor about how long you should not breastfeed after you stop the study treatment(s).

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You may or may not benefit from joining this research study. If we are able to successfully treat your tumor without the use of radiation, you will not have any of the short term or long term side effects of radiation treatment.  
We hope the information learned from this study will benefit other patients with medulloblastoma in the future.

Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from being in the study. However, medical care at Johns Hopkins is open to you as it is to all sick or injured people.  
x If you have health insurance: The costs for any treatment or hospital care you receive as the result of a study-related injury will be billed to your health insurer. Any costs that are not paid for by your health insurer will be billed to you.  
  
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x If you do not have health insurance: You will be billed for the costs of any treatment or hospital care you receive as the result of a study-related injury.  
By signing this form you will not give up any rights you have to seek compensation for injury.

If you think you are injured or ill because of this study, call Dr. Kenneth Cohen at 410-614-5055 during regular office hours.  
If you have an urgent medical problem related to your taking part in this study, call 410-955-6070 and ask for the Pediatric Oncologist on-call. This number is available 24 hours a day including weekends and holiday.  
If you are taking part at All Children's Hospital and you have a medical problem related to your taking part in this study, call Dr. Stacie Stapleton at 727-767-4176. If this doctor is not available, the operator will page the "on call physician."

While on the study, you are also at risk for the side effects described below. You should discuss these with the study doctor and/or your regular doctor. There also may be other side effects that we cannot predict. Other drugs will be given to make side effects less serious and uncomfortable. Many side effects go away shortly after the therapy is completed, but in some cases side effects can be serious or long-lasting or permanent. In rare cases, the side effects can lead to death. Other unknown side effects may occur. You will be watched closely and the treatment will be discontinued if serious side effects develop.  
- Physical exams
- Blood tests - Tests of kidney function - Tests of liver function - Tests of hormone function - Hearing tests - Magnetic Resonance Imaging (MRI) of brain and spine. - Evaluation of cerebral spinal fluid (CSF) taken by lumbar puncture* - Neuropsychological testing  
  
Approved May 11, 2016  
| Risks and side effects related to Lomustine include those which are:   |                                     |                                    |                                  |                 |
|------------------------------------------------------------------------|-------------------------------------|------------------------------------|----------------------------------|-----------------|
| Likely                                                                 | Less Likely                         | Rare but serious                   |                                  |                 |
| - Nausea and/or vomiting                                               | Increase in the blood of certain    | - Damage and scarring of the lungs |                                  |                 |
| - Fewer white blood cells, red blood                                   | that can lead to fluid in the lungs |                                    |                                  |                 |
| enzymes or bilirubin (a                                                |                                     |                                    |                                  |                 |
| cells and platelets in the blood                                       | substance that comes from the       | and affect your ability to breath  |                                  |                 |
| and the levels of oxygen in your                                       |                                     |                                    |                                  |                 |
| o                                                                      | a low number of white blood         | liver breaking down waste          |                                  |                 |
| cells can make it easier to get                                        | products) which could indicate      | blood. This usually occurs only    |                                  |                 |
| infections                                                             | liver irritation or damage.         | with very large doses over a long  |                                  |                 |
| o                                                                      | a low number of red blood           | .                                  | Inflammation and/or sores in the | period of time. |
| cells can make you feel tired                                          | mouth that may make                 | Damage to the lungs which may      |                                  |                 |
| and weak                                                               | swallowing difficult and are        | can become worse over time and     |                                  |                 |
| o                                                                      | a low number of platelets           | painful (painful mouth sores)      | lead to death                    |                 |
| (Confusion) difficulty in thinking                                     | Severe kidney damage (which         |                                    |                                  |                 |
| causes you to bruise and bleed                                         |                                     |                                    |                                  |                 |
| more easily                                                            | clearly or a sense of not knowing   | may be permanent)                  |                                  |                 |
| - Loss of Appetite                                                     | where you are                       | A decrease in the size of the      |                                  |                 |
| - Weight loss                                                          | .                                   | Tiredness                          | kidneys                          |                 |
| Unsteadiness when walking                                              | e Damage to the nerves of the eye   |                                    |                                  |                 |
| .                                                                      | Slurred speech                      | which may decrease vision (the     |                                  |                 |
| .                                                                      | ability to see clearly) and may     |                                    |                                  |                 |
| cause blindness                                                        |                                     |                                    |                                  |                 |
| - A new cancer or leukemia                                             |                                     |                                    |                                  |                 |
| resulting from this treatment                                          |                                     |                                    |                                  |                 |  
Risks and side effects related to the drugs given on this study include the following:  
| Risks and side effects related to Cisplatin include those which are:   |                                   |                                   |                                 |                                  |
|------------------------------------------------------------------------|-----------------------------------|-----------------------------------|---------------------------------|----------------------------------|
| Likely                                                                 | Less Likely                       | Rare but serious                  |                                 |                                  |
| .                                                                      | Nausea and vomiting               | Abnormal levels of certain salts  | Allergic reactions which may be |                                  |
| .                                                                      | fewer red blood cells and white   | in the body like sodium,          | severe and life-threatening,    |                                  |
| calcium, potassium and                                                 |                                   |                                   |                                 |                                  |
| blood cells and platelets in the                                       | causing difficulty in breathing,  |                                   |                                 |                                  |
| phosphate                                                              | rapid heart rate, facial swelling |                                   |                                 |                                  |
| blood                                                                  |                                   |                                   |                                 |                                  |
| o                                                                      | a low number of red blood         | .                                 | Metallic taste                  | and or a drop in blood pressure  |
| cells can make you feel tired                                          | Damage to the kidney which may    |                                   |                                 |                                  |
| .                                                                      | Rash                              |                                   |                                 |                                  |
| and weak                                                               | Numbness and tingling in the      | be permanent                      |                                 |                                  |
| .                                                                      |                                   |                                   |                                 |                                  |
| o                                                                      | a low number of white blood       | fingers and toes                  | .                               | Deafness                         |
| cells can make it easier to get                                        | .                                 | Temporary changes in vision       | .                               | Seizures                         |
| infections                                                             | .                                 | Damage to the ear causing         | .                               | Damage to the vision which could |
| o                                                                      | a low number of platelets         | hearing loss,  balance problems   | lead to blurred vision, blue-   |                                  |
| causes you to bruise and                                               | green color blindness and to loss |                                   |                                 |                                  |
| and ringing in the ears                                                |                                   |                                   |                                 |                                  |
| bleed more easily                                                      | .                                 | Elevation in the blood of certain | of vision which usually goes    |                                  |
| .                                                                      | Abnormal levels of magnesium      | away after stopping the drug      |                                 |                                  |
| enzymes found in the liver                                             |                                   |                                   |                                 |                                  |
| in the body which may require                                          | which may indicate liver          | Decrease in muscle and nerve      |                                 |                                  |
| .                                                                      |                                   |                                   |                                 |                                  |
| that you take extra magnesium                                          | irritation or damage              | reflexes that may affect normal   |                                 |                                  |
| by mouth or in the vein                                                | .                                 | Inflammation and discomfort in    | functions such as walking       |                                  |
| .                                                                      | Loss of appetite                  | Leukemia later in life            |                                 |                                  |
| the vein through which the                                             |                                   |                                   |                                 |                                  |
| .                                                                      | Damage to the ear causing         | medicine was given                |                                 |                                  |
| difficulty in hearing high pitched                                     | Damage to the skin if the         |                                   |                                 |                                  |
| sounds                                                                 | medication leaks from the vein    |                                   |                                 |                                  |
| .                                                                      | Temporary and mild increases      |                                   |                                 |                                  |
| in levels of certain chemicals in                                      |                                   |                                   |                                 |                                  |
| the blood because the kidney is                                        |                                   |                                   |                                 |                                  |
| not working as well as normal                                          |                                   |                                   |                                 |                                  |
Clinical trial: NCT02212574
Section: Procedures
Subsections: 3. What Will Happen If You Join This Study? If You Agree To Join This Study, We Will Ask You To Do The Following Things:

The only difference between the research therapy and the standard treatment for Wnt-positive medulloblastoma you will receive is that you will not receive radiation therapy or the weekly chemotherapy that is given during radiation treatment. All of the chemotherapy that is standardly given following radiation will occur, along with the normal monitoring during the chemotherapy treatment This is shown in the following pictures:  
  
  
Information about the standard chemotherapy and associated monitoring is included at the end of this  
 consent form.
Clinical trial: NCT02212574
Section: Purpose of Research
Subsections: 1. What You Should Know About This Study:

x You are being asked to join a research study. This consent form explains the research study and your part in it. Please read it carefully and take as much time as you need. Ask your study doctor or the study team to explain any words or information that you do not understand.  
x You are a volunteer. If you join the study, you can change your mind later. There will be no penalty or loss of benefits if you decide to quit the study.  
x During the study, we will tell you if we learn any new information that might affect whether you wish to continue to participate.  
x If we think your participation in this study may affect your clinical care, information about your study participation will be included in your medical record, which is used throughout Johns Hopkins. Doctors outside of Johns Hopkins may not have access to this information. You can ask the research team to send this information to any of your doctors.  
x When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital, Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All Children's Hospital.
Clinical trial: NCT02212574
Section: Withdrawal from Study
Subsections: 8. Will It Cost You Anything To Be In This Study? No. 9. Will You Be Paid If You Join This Study? No. 10. Can You Leave The Study Early?|11. Why Might We Take You Out Of The Study Early?

x You can agree to be in the study now and change your mind later. x If you wish to stop, please tell us right away. x Leaving this study early will not stop you from getting regular medical care. x If you leave the study early, Johns Hopkins may use or give out your health information that it already has if the information is needed for this study or any follow-up activities.

You may be taken out of the study if:
x Your cancer gets worse or the side effects from the study drug are too dangerous. x Staying in the study would be harmful.  
x It is not in your best interest to do so.  
x You need treatment not allowed in this study.  
x You fail to follow instructions. x You become pregnant.  
x The study is cancelled.  
There may be other reasons that we don't know at this time to take you out of the study.