Clinical trial: NCT01434602
Section: Alternatives
Subsections: Alternative Approaches Or Treatments

Instead of being in this study, you have these options:
- Getting treatment or care for your cancer without being in a study  
- Taking part in another study
- 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. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.
Clinical trial: NCT01434602
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
- The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
- National Cancer Institute Institutional Review Board - Brain Tumor Trials Collaborative (BTTC), Novartis (drug supplier) and its authorized agents, and Bayer Pharmaceuticals
- Governmental agencies in other countries where the study drug may be considered for approval
A description of this clinical trial will be available on http://www.Clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most the Web site will include a summary of the results. You can search this Web site at any time.

To help us protect your privacy, we have obtained a Certificate of Confidentiality. The researchers can use this Certificate to legally refuse to disclose information that may identify you  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
  
in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. You should also know that there are several circumstances in which the Certificate does not provide coverage. These include when information:  
- will be used for auditing or program evaluation internally by the NIH; or - must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
- is necessary for your medical treatment and you have consented to this disclosure;
- is for other research.
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information. The Certificate of Confidentiality will not protect against the required reporting by hospital staff of information on suspected child abuse, reportable communicable diseases, and/or possible threat of harm to self or others.
Clinical trial: NCT01434602
Section: Duration of Study Involvement
Subsections: During The Study|When You Are Finished Taking The Drugs|This Consent Document Has Been Approved For Use From July 28, 2020 Through **July 27, 2021.**

If you are found to be eligible to take part in this study, you will be assigned to a study phase based on when you join this study. If you are enrolled in Phase 1, you will be assigned to 1 of 6 dose levels of the combination of everolimus and sorafenib based on when you join this study. You will remain on the same dose level for the entire study. Up to 3 participants will be enrolled at each dose level. The first 3 participants in each group will receive the lowest dose level. Each set of 3 new participants will receive a higher dose than the one before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of study drugs given in combination is found. If you are enrolled in Phase 2, you will receive the combination of everolimus and sorafenib at the highest dose and on the same schedule that was tolerated in Phase 1. Study Drug Administration Each cycle is 28 days. You will take everolimus by mouth 1 time a day every day while you are on study. You should take everolimus whole without chewing them. You should take everolimus without food (1 hour before or 2 hours after eating), with at least 1 cup (8 oz.) of water in the morning, at the same time each day. You will take sorafenib by mouth 2 times each day on Days 1-7 and Days 15-21 of every cycle. You should take sorafenib without food (1 hour before or 2 hours after eating), with at least 1 cup (8 oz.) of water. You may take the study drugs at the same time. Your study doctor will tell you about any changes needed in the way you take the medicine.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
  
It is very important for you to take the study drug just as the study doctor tells you. Do not skip any doses unless your study doctor tells you to skip doses. If you throw up after taking the study drug, you should NOT take another tablet that day. Let your study doctor know that you got sick. If you do forget to take the study drug one day, do not take any extra doses the next day. Call your study doctor and ask for advice. During the study, you must talk to the study doctor before you take any drug other than the study drug. This includes homeopathic, alternative, or herbal medicines, and vitamins. Please avoid eating grapefruit, star fruit, and Seville oranges or drinking their juices while in the study. The juices in these fruits can change the way your body treats or breaks down everolimus (Afinitor®).  
You will be given a study drug diary where you will write down the study drugs that you take at home. You should also bring the diary, study drug, and any empty bottles, with you to each study visit. Study Visits Every 2 weeks:
- Blood (about 1-2 teaspoons) will be drawn for routine tests.  
Every 4 weeks:  
- You will have a physical exam and neurologic exam.  
- Routine blood and urine tests - You will be asked about any drugs you may be taking and if you have had any side effects. (For the first cycle, this is every week if you are in Phase 1.)
- Your blood pressure will be recorded (For the first cycle, this is every week).
Every 4 weeks for the first 2 cycles or the first 4 cycles (if you received bevacizumab previously), then every 8 weeks:  
- You will have a brain MRI scan or CT scans to check the status of the disease. - You will complete the quality-of-life questionnaire which will take about 5 minutes.
At any time during the study, extra tests may be performed if the doctor thinks they are needed for your safety. The study doctor will tell you more about any extra tests.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent

At the end of the study, give any study medicine or empty containers you still have to your study doctor or nurse. After you stopped taking the study drugs, the study staff will call you every 3 months to check how you are doing. Each phone call will take about 5 minutes.

Signature of Investigator Date Signature of Witness Date Print Name Print Name PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL **RESEARCH**
STUDY (Continuation **Sheet)**
- Adult Patient or - Parent, for Minor Patient NIH-2514-1 (07-09) P.A.: 09-25-0099 File in Section 4: Protocol Consent
Clinical trial: NCT01434602
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
| PATIENT IDENTIFICATION   | CONTINUATION SHEET for either: NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent   |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|  
- You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
- Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT01434602
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation|Sorafenib Side Effects|Everolimus Side Effects|Frequency Unknown But Possibly Occurring In 1-10% Of Patients|Other Risks|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?|Research Related Injury

While on this study, you are at risk for side effects. These side effects will vary from person to person. The more commonly occurring side effects are listed in this form, as are rare but serious side effects. You should discuss these with the study doctor. You may also want to ask about uncommon side effects that have been observed in small numbers of patients but are not listed in this form. Many side effects go away shortly after treatment is stopped, but in some cases, side effects may be serious, long-lasting or permanent, and may even cause death. Tell the study staff about any side effects that you may have, even if you do not think they are related to the study drugs. Sorafenib and everolimus each may cause low blood cell counts (red blood cells, platelets, and/or white blood cells):  
- A low red blood cell count (anemia) may cause difficulty breathing and/or fatigue. You may need a blood transfusion.  
- A low platelet count increases your risk of bleeding (such as nosebleeds, bruising, stroke, and/or digestive system bleeding). You may need a platelet transfusion.  
- A low white blood cell count increases your risk of infection (such as pneumonia and/or severe blood infection). Infections may occur anywhere and become life-threatening. Symptoms of infection may include fever, pain, redness, and difficulty breathing.
for  
  
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 16-C-0011 CONTINUATION: page 7 of 17 pages  
| Likely (occurring in more than 20% of patients)   |                                                                                            |    |                                                                                                                                                                                                |
|---------------------------------------------------|--------------------------------------------------------------------------------------------|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -                                                 | fatigue                                                                                    |    |                                                                                                                                                                                                |
| -                                                 | skin rash                                                                                  |    |                                                                                                                                                                                                |
| -                                                 | skin peeling                                                                               |    |                                                                                                                                                                                                |
| -                                                 | shedding of skin                                                                           |    |                                                                                                                                                                                                |
| -                                                 | hand-foot syndrome  (palms of hands/soles of  feet having pain,  swelling, and blistering) |    |                                                                                                                                                                                                |
| -                                                 | hair loss (partial or total)                                                               | -  | abnormal salts, minerals,  and/or acids in the blood  (possible weakness,  swelling, fatigue, low  blood pressure, organ  failure, heart problems,  changes in mental status,  and/or seizure) |
| -                                                 | abnormal digestive blood  tests (possible pancreas  damage)                                | -  | diarrhea                                                                                                                                                                                       |
| -                                                 | abdominal pain                                                                             |    |                                                                                                                                                                                                |
| -                                                 | weight loss                                                                                |    |                                                                                                                                                                                                |
| -                                                 | loss of appetite                                                                           |    |                                                                                                                                                                                                |
| -                                                 | nausea                                                                                     |    |                                                                                                                                                                                                |
| -                                                 | increased risk of bleeding                                                                 |    |                                                                                                                                                                                                |
| -                                                 | low blood cell counts (red/  white/platelets)                                              |    |                                                                                                                                                                                                |

Less Likely (occurring in 3-20% of patients)
Exact frequency unknown but occurring in between 1 and 10% of patients:  
| -   | high blood pressure                  |    |          |
|-----|--------------------------------------|----|----------|
| -   | decreased blood supply to  the heart |    |          |
| -   | heart attack                         |    |          |
| -   | nerve damage (loss of  feeling)      | -  | headache |
| -   | itching                              |    |          |
| -   | dry skin                             |    |          |
| -   | skin redness                         |    |          |
| -   | vomiting                             |    |          |
| -   | constipation                         |    |          |  
| -   | liver problems       |
|-----|----------------------|
| -   | pain (muscle/joint)  |
| -   | weakness             |
| -   | difficulty breathing |
| -   | cough                |  
| -   | flushing                                                                  |    |                  |
|-----|---------------------------------------------------------------------------|----|------------------|
| -   | depression                                                                |    |                  |
| -   | fever                                                                     |    |                  |
| -   | acne                                                                      |    |                  |
| -   | shedding and scaling of  the skin (possible fatal  loss of bodily fluids) | -  | loss of appetite |
| -   | upset stomach                                                             |    |                  |
| -   | difficulty swallowing                                                     |    |                  |
| -   | tongue pain                                                               |    |                  |
| -   | inflammation of the  mucous membranes                                     |    |                  |
| -   | mouth blisters/sores  (possible difficulty  swallowing)                   |    |                  |  
| -   | dry mouth                                     |
|-----|-----------------------------------------------|
| -   | impotence                                     |
| -   | low red blood cell counts                     |
| -   | abnormal liver tests  (possible liver damage) |
| -   | kidney failure                                |
| -   | hoarseness                                    |
| -   | flu-like symptoms                             |  
| Rare but serious (occurring in fewer than 3% of patients)   |                                                                                                                           |                  |                     |                          |            |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------|---------------------|--------------------------|------------|
| -                                                           | irregular heartbeat                                                                                                       | -                | low blood levels of | -                        | nosebleeds |
| -                                                           | heart failure                                                                                                             | sodium (possible | -                   | build-up of fluid around |            |
| PATIENT IDENTIFICATION                                      | CONTINUATION SHEET for either: NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent |                  |                     |                          |            |  
for NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 16-C-0011 CONTINUATION: page 8 of 17 pages  
| -                                                                                       | heart attack                                                                                                                                                            |                                              |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| -                                                                                       | tear of the main artery of  the heart                                                                                                                                   |                                              |
| -                                                                                       | severe increase in blood  pressure (possible stroke)                                                                                                                    |                                              |
| -                                                                                       | bleeding in the brain                                                                                                                                                   |                                              |
| -                                                                                       | brain damage that may be  reversible (possible  headache, confusion,  seizures, and/or vision  loss)                                                                    |                                              |
| -                                                                                       | blood clot blocking a  blood vessel (possibly in  the heart and brain)                                                                                                  |                                              |
| -                                                                                       | temporary stroke  symptoms                                                                                                                                              |                                              |
| -                                                                                       | very severe blistering skin  disease (loss of large  portion of skin)                                                                                                   |                                              |
| -                                                                                       | very severe blistering skin  disease (with ulcers of  the skin and digestive  tract)                                                                                    |                                              |
| -                                                                                       | tissue swelling                                                                                                                                                         |                                              |
| -                                                                                       | underactive thyroid gland  (possible weight gain,  heart failure, and/or  constipation)                                                                                 |                                              |
| -                                                                                       | overactive thyroid gland  (possible weight loss,  heart rate changes, and/or  sweating)                                                                                 | headache, confusion,  seizures, and/or coma) |
| -                                                                                       | dehydration                                                                                                                                                             |                                              |
| -                                                                                       | bleeding in the digestive  system                                                                                                                                       |                                              |
| -                                                                                       | hole in the intestines  (possibly leaking  contents into the  abdomen)                                                                                                  |                                              |
| -                                                                                       | inflammation of the  pancreas (possible  abdominal pain)                                                                                                                |                                              |
| -                                                                                       | gallbladder inflammation  (possible abdominal pain)                                                                                                                     |                                              |
| -                                                                                       | jaundice (yellowing of  skin and/or eyes                                                                                                                                |                                              |
| -                                                                                       | liver failure                                                                                                                                                           |                                              |
| -                                                                                       | liver damage due to  inflammation                                                                                                                                       |                                              |
| -                                                                                       | bone destruction (jaw  bone)                                                                                                                                            |                                              |
| -                                                                                       | breakdown of muscle  tissue (possible kidney  failure)                                                                                                                  |                                              |
| -                                                                                       | decreased kidney function  (possible kidney failure                                                                                                                     |                                              |
| -                                                                                       | bleeding in the esophagus                                                                                                                                               | the lungs                                    |
| -                                                                                       | bleeding in the airways                                                                                                                                                 |                                              |
| -                                                                                       | lung inflammation  (possible difficulty  breathing)                                                                                                                     |                                              |
| -                                                                                       | allergic reaction (such as  skin reaction and/or  hives)                                                                                                                |                                              |
| -                                                                                       | life-threatening allergic  reaction (such as  difficulty breathing, low  blood pressure, and/or  organ failure)                                                         |                                              |
| -                                                                                       | infection                                                                                                                                                               |                                              |
| -                                                                                       | preeclampsia-like  syndrome (high blood  pressure and increased  proteins in the urine  [possible kidney  damage])                                                      |                                              |
| -                                                                                       | pain at the tumor site                                                                                                                                                  |                                              |
| -                                                                                       | breakdown products of the  cancer cells entering the  blood stream (possible  weakness, low blood  pressure, muscle cramps,  kidney damage, and/or  other organ damage) |                                              |
| -                                                                                       | delayed wound healing                                                                                                                                                   |                                              |
| Sorafenib may cause you to develop another type of cancer (such as skin cancer and lung |                                                                                                                                                                         |                                              |  
Sorafenib may cause you to develop another type of cancer (such as skin cancer and lung cancer).

| Likely (occurring in more than 20% of patients)   |                                                                                                                           |    |                 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----|-----------------|
| -                                                 | swelling (arm/leg)                                                                                                        |    |                 |
| -                                                 | high blood pressure                                                                                                       |    |                 |
| -                                                 | fatigue                                                                                                                   | -  | low blood sugar |
| -                                                 | abnormal salts, minerals,  and/or acids in the blood                                                                      | -  | abnormal taste  |
| -                                                 | low blood cell counts (red,  white, platelets)                                                                            |    |                 |
| PATIENT IDENTIFICATION                            | CONTINUATION SHEET for either: NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent |    |                 |  
for NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 16-C-0011 CONTINUATION: page 9 of 17 pages  
| -                                            | fever                                                                                                               |                                                                                                                                          |                            |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| -                                            | headache                                                                                                            |                                                                                                                                          |                            |
| -                                            | seizure                                                                                                             |                                                                                                                                          |                            |
| -                                            | anxiety                                                                                                             |                                                                                                                                          |                            |
| -                                            | aggression                                                                                                          |                                                                                                                                          |                            |
| -                                            | behavioral disturbance                                                                                              |                                                                                                                                          |                            |
| -                                            | skin rash and/or itching                                                                                            |                                                                                                                                          |                            |
| -                                            | acne                                                                                                                |                                                                                                                                          |                            |
| -                                            | nail changes                                                                                                        |                                                                                                                                          |                            |
| -                                            | high blood levels of fat  (possible heart disease  and/or stroke)                                                   |                                                                                                                                          |                            |
| -                                            | high blood sugar (possible  diabetes)                                                                               | (possible weakness,  swelling, fatigue, low  blood pressure, organ  failure, heart problems,  changes in mental status,  and/or seizure) |                            |
| -                                            | mouth blisters/sores                                                                                                |                                                                                                                                          |                            |
| -                                            | loss of appetite                                                                                                    |                                                                                                                                          |                            |
| -                                            | weight loss                                                                                                         |                                                                                                                                          |                            |
| -                                            | diarrhea                                                                                                            |                                                                                                                                          |                            |
| -                                            | constipation                                                                                                        |                                                                                                                                          |                            |
| -                                            | abdominal pain                                                                                                      |                                                                                                                                          |                            |
| -                                            | nausea                                                                                                              |                                                                                                                                          |                            |
| -                                            | vomiting                                                                                                            | -                                                                                                                                        | increased risk of bleeding |
| -                                            | abnormal liver test  (possible liver damage  and/or yellowing of the  skin and/or eyes)                             |                                                                                                                                          |                            |
| -                                            | weakness                                                                                                            |                                                                                                                                          |                            |
| -                                            | abnormal kidney test  (possible kidney damage)                                                                      |                                                                                                                                          |                            |
| -                                            | cough                                                                                                               |                                                                                                                                          |                            |
| -                                            | nosebleed                                                                                                           |                                                                                                                                          |                            |
| -                                            | difficulty breathing                                                                                                |                                                                                                                                          |                            |
| -                                            | infection                                                                                                           |                                                                                                                                          |                            |
| Less Likely (occurring in 3-20% of patients) |                                                                                                                     |                                                                                                                                          |                            |
| -                                            | chest pain (possibly due to  heart trouble)                                                                         |                                                                                                                                          |                            |
| -                                            | fast heartbeat                                                                                                      |                                                                                                                                          |                            |
| -                                            | chills                                                                                                              |                                                                                                                                          |                            |
| -                                            | migraine                                                                                                            |                                                                                                                                          |                            |
| -                                            | dizziness                                                                                                           |                                                                                                                                          |                            |
| -                                            | difficulty sleeping                                                                                                 |                                                                                                                                          |                            |
| -                                            | depression                                                                                                          |                                                                                                                                          |                            |
| -                                            | dry skin                                                                                                            |                                                                                                                                          |                            |
| -                                            | skin peeling, redness,  and/or sores                                                                                |                                                                                                                                          |                            |
| -                                            | breaking of nails                                                                                                   |                                                                                                                                          |                            |
| -                                            | eczema (skin  inflammation)                                                                                         |                                                                                                                                          |                            |
| -                                            | hair loss (partial or total)                                                                                        |                                                                                                                                          |                            |
| -                                            | hand-foot syndrome  (palms of hands/soles of  feet having pain,  swelling, and blistering)                          | -                                                                                                                                        | diabetes                   |
| -                                            | abnormal blood levels of  fat                                                                                       |                                                                                                                                          |                            |
| -                                            | dry mouth                                                                                                           |                                                                                                                                          |                            |
| -                                            | upset stomach                                                                                                       |                                                                                                                                          |                            |
| -                                            | inflammation of the  stomach and/or intestines                                                                      |                                                                                                                                          |                            |
| -                                            | hemorrhoids                                                                                                         |                                                                                                                                          |                            |
| -                                            | difficult and/or painful  urination                                                                                 |                                                                                                                                          |                            |
| -                                            | blood in the urine                                                                                                  |                                                                                                                                          |                            |
| -                                            | uterine and/or vaginal  bleeding                                                                                    |                                                                                                                                          |                            |
| -                                            | changed, painful, heavy,  or stopped menstrual  cycle                                                               |                                                                                                                                          |                            |
| -                                            | pain (jaws/joint/arm/leg/  back)                                                                                    |                                                                                                                                          |                            |
| -                                            | muscle spasms                                                                                                       | -                                                                                                                                        | tremors                    |
| -                                            | abnormal sensation (such  as pins and needles)                                                                      |                                                                                                                                          |                            |
| -                                            | swelling (eyelid)                                                                                                   |                                                                                                                                          |                            |
| -                                            | red eyes                                                                                                            |                                                                                                                                          |                            |
| -                                            | kidney failure                                                                                                      |                                                                                                                                          |                            |
| -                                            | build-up of fluid around  the lungs                                                                                 |                                                                                                                                          |                            |
| -                                            | lung inflammation  (possible difficulty breathing)                                                                  |                                                                                                                                          |                            |
| -                                            | stuffy/runny nose                                                                                                   |                                                                                                                                          |                            |
| -                                            | difficulty swallowing                                                                                               |                                                                                                                                          |                            |
| -                                            | sore throat                                                                                                         |                                                                                                                                          |                            |
| -                                            | life-threatening allergic  reaction (such as  difficulty breathing,  flushing, chest pain,  and/or tissue swelling) |                                                                                                                                          |                            |

| -                      | low blood pressure                                                                                                        | -   | high blood levels of uric   | -   | weakening or loss of bone   |
|------------------------|---------------------------------------------------------------------------------------------------------------------------|-----|-----------------------------|-----|-----------------------------|
| PATIENT IDENTIFICATION | CONTINUATION SHEET for either: NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent |     |                             |     |                             |  
for NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 16-C-0011 CONTINUATION: page 10 of 17 pages  
| (possible  dizziness/fainting)                            |                                                                                                          |                                                        |                                                             |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------|
| -                                                         | irregular heartbeat                                                                                      |                                                        |                                                             |
| -                                                         | swelling                                                                                                 |                                                        |                                                             |
| -                                                         | blood clots in a vein  (possible pain, swelling,  and/or redness)                                        |                                                        |                                                             |
| -                                                         | fainting                                                                                                 |                                                        |                                                             |
| -                                                         | agitation                                                                                                |                                                        |                                                             |
| -                                                         | hallucinations (seeing or  hearing things that are  not there)                                           |                                                        |                                                             |
| -                                                         | weakness on one side of  the body                                                                        |                                                        |                                                             |
| -                                                         | hair growth                                                                                              |                                                        |                                                             |
| -                                                         | opening of a wound                                                                                       |                                                        |                                                             |
| -                                                         | dehydration                                                                                              |                                                        |                                                             |
| -                                                         | sweating/night sweats                                                                                    |                                                        |                                                             |
| -                                                         | change in body  appearance due to high  levels of steroid hormone                                        |                                                        |                                                             |
| -                                                         | overactive thyroid gland  (possible weight loss,  heart rate changes, and/or  sweating)                  | acid (possible painful  joints and/or kidney  failure) |                                                             |
| -                                                         | vomiting of blood                                                                                        |                                                        |                                                             |
| -                                                         | paralysis of the intestines                                                                              |                                                        |                                                             |
| -                                                         | swelling of the scrotum                                                                                  |                                                        |                                                             |
| -                                                         | abdominal pain                                                                                           |                                                        |                                                             |
| -                                                         | gas                                                                                                      |                                                        |                                                             |
| -                                                         | heartburn                                                                                                |                                                        |                                                             |
| -                                                         | thickened gums                                                                                           |                                                        |                                                             |
| -                                                         | abdominal wall  inflammation                                                                             |                                                        |                                                             |
| -                                                         | inability to urinate                                                                                     |                                                        |                                                             |
| -                                                         | frequent urination                                                                                       |                                                        |                                                             |
| -                                                         | urge to urinate                                                                                          |                                                        |                                                             |
| -                                                         | impotence                                                                                                |                                                        |                                                             |
| -                                                         | ovarian cysts (fluid-filled  lump)                                                                       |                                                        |                                                             |
| -                                                         | increase in                                                                                              |                                                        |                                                             |
| -                                                         | infection-fighting cells                                                                                 |                                                        |                                                             |
| -                                                         | lymph node swelling                                                                                      |                                                        |                                                             |
| -                                                         | high blood platelet count  (possible increased  clotting)                                                |                                                        |                                                             |
| -                                                         | bone destruction                                                                                         | strength (possible broken  bones)                      |                                                             |
| -                                                         | inflammation of bone in  the spine                                                                       |                                                        |                                                             |
| -                                                         | painful joint inflammation                                                                               |                                                        |                                                             |
| -                                                         | pain (muscle/joint)                                                                                      |                                                        |                                                             |
| -                                                         | joint swelling                                                                                           |                                                        |                                                             |
| -                                                         | blurry vision                                                                                            |                                                        |                                                             |
| -                                                         | cataracts (clouding of the  lens of the eye)                                                             |                                                        |                                                             |
| -                                                         | back-up of urine into the  kidney                                                                        |                                                        |                                                             |
| -                                                         | kidney inflammation  (possible kidney  damage/failure)                                                   |                                                        |                                                             |
| -                                                         | blood clot in an artery to  the kidney (possible  kidney damage or loss of  function)                    |                                                        |                                                             |
| -                                                         | decreased kidney function                                                                                |                                                        |                                                             |
| -                                                         | fluid in the lung (possible  difficulty breathing)                                                       |                                                        |                                                             |
| -                                                         | wheezing                                                                                                 |                                                        |                                                             |
| Rare but serious (occurring in fewer than 3% of patients) |                                                                                                          |                                                        |                                                             |
| -                                                         | heart failure                                                                                            |                                                        |                                                             |
| -                                                         | sudden stopping of the  heart                                                                            |                                                        |                                                             |
| -                                                         | multiple blood clots  possible organ  dysfunction and/or  failure)                                       |                                                        |                                                             |
| -                                                         | blood clot at the site of a  graft                                                                       | -                                                      | decreased brain function  (possible paralysis and/or  coma) |
| -                                                         | wound healing problems                                                                                   |                                                        |                                                             |
| -                                                         | abnormal blood clotting in  small blood vessels  (possible stroke and/or  other organ damage)            |                                                        |                                                             |
| -                                                         | inflammation of the  pancreas (possible  abdominal pain)                                                 | -                                                      | low sperm count                                             |
| -                                                         | slowing or stoppage in the  normal flow of bile  (possible body yellowing                                |                                                        |                                                             |
| -                                                         | and/or abdominal pain)                                                                                   |                                                        |                                                             |
| -                                                         | severe life-threatening  infection (possible low  blood pressure, kidney  failure, and/or heart  failure |                                                        |                                                             |  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
  
Everolimus may rarely cause you to develop another type of cancer (such as lymphoma [a type of lymph node cancer] and/or skin cancer [such as melanoma]). It could also cause thickening in the lining of the uterus and uterine fibroids. If you have had hepatitis (liver inflammation) in the past, taking everolimus may rarely cause the hepatitis to come back, which may cause death. You must not drink grapefruit juice or eat grapefruit products while taking everolimus. For those patients receiving Everolimus in combination with Sorafenib, there is a rare complication of muscle weakness, muscle cramps, stiffness and spasm, muscle pain in the shoulders, thighs, or lower back; trouble moving arms and legs; and dark red or brown urine or decreased urination.  
Symptoms may occur in one area of the body or affect the whole body. This complication may occur in both early and later stages of treatment. The severity of the symptoms will vary and in rare cases, it can lead to death.  
Using the **study drugs together** may cause side effects that are not seen when each is given alone.  
The study drug combination may also increase the frequency and/or severity of the side effects listed above.

Blood draws may cause pain, bleeding, and/or bruising. You may faint and/or develop an infection with redness and irritation of the vein at the site where blood is drawn. Frequent blood collection may cause anemia (low red blood cell count), which may create a need for blood transfusions. Questionnaires may contain questions that are sensitive in nature. You may refuse to answer any question that makes you feel uncomfortable. If you have concerns about completing the questionnaire, you are encouraged to contact your doctor or the Principal Investigator. This study may involve unpredictable risks to the participants.

The aim of this study is to determine a safe dose and to see if this experimental treatment will cause your tumors to shrink. We do not know if you will receive personal medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the drug's effect on your cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent

If you are injured while participating in this study, principal investigator will provide you with treatment per the NIH Clinical Center Research Injury Policy (Item \# 2 on page 16). Novartis (drug supplier) will not pay any money to you or your medical bills.
Clinical trial: NCT01434602
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

This is an investigational study. Everolimus is FDA approved and commercially available for the treatment of kidney cancer and certain types of brain tumors. It is designed to block a special protein in tumor cells and block the formation of new blood vessels, which is important in tumor  
PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY  
- Adult Patient or - Parent, for Minor Patient  
NIH-2514-1 (07-09)  
P.A.: 09-25-0099 File in Section 4: Protocol Consent (1)  
growth. Sorafenib is FDA approved and commercially available for the treatment of kidney cancer. Sorafenib is designed to stop cell growth and to block the formation of new blood vessels (the tubes that carry blood around the body), which are involved in the growth and development of tumors. The combination of everolimus and sorafenib to treat brain tumors is investigational. At this time, this combination is only being used in research. The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and best schedule of the combination of everolimus and sorafenib that can be given to patients with malignant glioma. The goal of Phase 2 of this study to learn if the combination of everolimus and sorafenib can help to control malignant glioma. The safety of this combination will also be studied in both phases.

You are being asked to take part in this study because you have malignant glioma (such as glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma) that has returned after treatment.
Clinical trial: NCT01434602
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:
- if your disease comes back during treatment  
- if you become pregnant while on study therapy
- if you have side effects from the treatment that your doctor thinks are too severe
In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to Brain Tumor Trials Collaborative (BTTC), Novartis (drug supplier) and its authorized agents, and Bayer Pharmaceuticals or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.