Clinical trial: NCT01295944
Section: Alternatives
Subsections: Alternative Approaches Or Treatments

What other choices do I have if I do not take part in this study?  
Instead of being in this study, you have these options:
- You may choose to receive other treatments for recurrent ependymoma (such as chemotherapy [such as temozolomide], radiation therapy, or a combination of both)
- Taking part in another study, if available.  
- Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly. 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: NCT01295944
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?

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
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.  
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
Clinical trial: NCT01295944
Section: Duration of Study Involvement
Subsections: During The Study|How Long Will I Be In This Study?

If you are found to be eligible to take part in this study you will receive carboplatin by vein over 30 minutes on Day 1 of each 28-day cycle. You will receive bevacizumab by vein over 90 minutes on Days 1 and 15 of each cycle. Study Visits Every week:
- Blood (about 1-2 teaspoons) will be drawn for routine tests.  
Every 4 weeks:  
- Urine will be collected to check your kidney function. - You will be asked about any drugs you may be taking and if you have had any side effects.  
Every 8 weeks:
- Your medical history will be recorded.  
- You will have a physical exam, including measurement of your vital signs.  
- You will have a neurological exam.  
- Your performance status will be recorded.  
- You will complete the quality of life questionnaire. - You will have an MRI scan or CT scan of the head and/or spine to check the status of the disease.
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.

You will receive up to 6 cycles of the study drug combination. You will be taken off study early if the disease gets worse or you experience intolerable side effects. If the disease has not gotten worse after 6 cycles of receiving the study drug combination, you will be able to continue receiving bevacizumab alone for as long as the doctor thinks it is in your best interest. You will continue to follow the same study visit schedule detailed above.
Clinical trial: NCT01295944
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:  
- 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.  
- You will not be paid for taking part in this study.
For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute's Web site at http://cancer.gov/clinicaltrials/understanding/insurance-coverage. You can print a copy of the "Clinical Trials and Insurance Coverage" information from this Web site. Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237) and ask them to send you a free copy.
Clinical trial: NCT01295944
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect **From Being In This Study?**|Carboplatin Side Effects|Other Risks|Potential Benefits Of Participation What Possible Benefits Can I Expect From Taking Part In This Study?|Optional Procedure Risks

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.  
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  
Carboplatin and bevacizumab 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.

| Likely (occurring in more than 20% of patients)           |                                                                                                                                                                                               |    |                                                                     |    |                                               |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|---------------------------------------------------------------------|----|-----------------------------------------------|
| -                                                         | 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) | -  | vomiting                                                            | -  | abnormal liver tests  (possible liver damage) |
| -                                                         | abnormal kidney test  (possible kidney damage                                                                                                                                                 |    |                                                                     |    |                                               |
| -                                                         | low blood counts  (red, white, platelets)                                                                                                                                                     |    |                                                                     |    |                                               |
| -                                                         | pain                                                                                                                                                                                          |    |                                                                     |    |                                               |
| Less Likely (occurring in 3-20% of patients)              |                                                                                                                                                                                               |    |                                                                     |    |                                               |
| -                                                         | nerve damage (possible  numbness, pain, and/or loss  of motor function)                                                                                                                       |    |                                                                     |    |                                               |
| -                                                         | hair loss (partial or total)                                                                                                                                                                  |    |                                                                     |    |                                               |
| -                                                         | abdominal pain                                                                                                                                                                                |    |                                                                     |    |                                               |
| -                                                         | nausea                                                                                                                                                                                        | -  | constipation                                                        | -  | weakness                                      |
| -                                                         | diarrhea                                                                                                                                                                                      | -  | abnormal liver tests  (possible yellowing of  the skin and/or eyes) |    |                                               |
| -                                                         | allergic reaction                                                                                                                                                                             |    |                                                                     |    |                                               |
| -                                                         | infection                                                                                                                                                                                     |    |                                                                     |    |                                               |
| -                                                         | abnormal taste                                                                                                                                                                                |    |                                                                     |    |                                               |
| -                                                         | mouth blisters/sores  (possible difficulty  swallowing)                                                                                                                                       |    |                                                                     |    |                                               |
| Rare but serious (occurring in fewer than 3% of patients) |                                                                                                                                                                                               |    |                                                                     |    |                                               |
| -                                                         | high blood pressure                                                                                                                                                                           | -  | multiple blood clots  (possible organ  dysfunction and/or  failure) |    |                                               |
| -                                                         | reduced blood supply  to the arms and legs                                                                                                                                                    |    |                                                                     |    |                                               |
| -                                                         | visual problems                                                                                                                                                                               | -  | difficulty breathing due  to narrowing of the  airways              |    |                                               |
| -                                                         | tissue death at the  injection site caused by  drug leakage                                                                                                                                   |    |                                                                     |    |                                               |
| -                                                         | life-threatening allergic                                                                                                                                                                     |    |                                                                     |    |                                               |
| -                                                         | low blood pressure (possible  dizziness/fainting)                                                                                                                                             |    |                                                                     |    |                                               |
| -                                                         | heart failure                                                                                                                                                                                 |    |                                                                     |    |                                               |
| -                                                         | stroke                                                                                                                                                                                        |    |                                                                     |    |                                               |
| -                                                         | dehydration                                                                                                                                                                                   |    |                                                                     |    |                                               |
| 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-0009 CONTINUATION: page 6 of 13 pages  
| -   | blood vessel blockage                         | -   | blindness    |
|-----|-----------------------------------------------|-----|--------------|
| -   | anemia due to destruction of  red blood cells | -   | hearing loss |  
| reaction (such as  difficulty breathing, low  blood pressure, and/or  organ failure)   |
|----------------------------------------------------------------------------------------|  
Carboplatin may cause you to develop another type of cancer (such as skin cancer and lung cancer).  
| Bevacizumab Side Effects Likely (occurring in more than 20% of patients) - high blood pressure - loss of appetite - failure of the ovaries to  produce hormones,  which may be permanent  (possible stopped  menstrual cycle) - bleeding  - nosebleed - low white blood cell  counts  - difficulty breathing - weakness - abnormal kidney test  (possible kidney damage) - blood clots in a vein  (possible pain, swelling,  and/or redness)  - pain - nerve damage (loss of  sensory function)  - headache - dizziness - fatigue - hair loss (partial or total) - abdominal pain  - constipation  - diarrhea - mouth blisters/sores  (possible difficulty  swallowing) - digestive system  bleeding  - upset stomach - vomiting - abnormal taste Less Likely (occurring in 3-20% of patients) - blood clots in an artery  (possible organ damage  such as stroke and/or  heart attack) - low blood pressure  (possible  dizziness/fainting)  - heart failure - fainting - bleeding in the brain  and/or spinal cord  - stroke  - shedding and scaling of  the skin (possible fatal  loss of bodily fluids) - change of skin color  - low blood levels of  sodium (possible  headache, confusion,  seizures, and/or coma)  - dehydration - gas - dry mouth  - hole in the intestines  - inflammation or paralysis  of the intestines  - weight loss - nausea  - uterine and/or vaginal  bleeding  - low platelet cell counts - pain (back/muscle)  - voice changes - runny nose  - lung inflammation  (possible difficulty 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-0009 CONTINUATION: page 7 of 13 pages  
| -   | difficulty walking   |
|-----|----------------------|
| -   | dry skin             |
| -   | skin sores           |
| -   | opening of a wound   |  
| (possibly leaking  contents into the  abdomen)   |               |
|--------------------------------------------------|---------------|
| -                                                | bleeding gums |  
| breathing)   |                                                    |
|--------------|----------------------------------------------------|
| -            | infusion reaction  (possible chills and/or  hives) |  
| Rare but serious (occurring in fewer than 3% of patients)   |                                                                                                      |    |                                                                                                                 |    |          |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----|-----------------------------------------------------------------------------------------------------------------|----|----------|
| -                                                           | severe heart problems                                                                                | -  | stomach and/or small  intestine ulcer                                                                           | -  | deafness |
| -                                                           | heart attack                                                                                         | -  | kidney failure                                                                                                  |    |          |
| -                                                           | vein blockage in the  abdomen                                                                        |    |                                                                                                                 |    |          |
| -                                                           | chest pain due to heart  trouble                                                                     | -  | decreased kidney  function (possible kidney  failure)                                                           |    |          |
| -                                                           | hole in the gall bladder  (possible abdominal  pain, gall stones, nausea,  and/or infection)         |    |                                                                                                                 |    |          |
| -                                                           | severe increase in blood  pressure (possible stroke)                                                 | -  | coughing up blood                                                                                               |    |          |
| -                                                           | brain injury that may be  reversible (possible  headache, confusion,  seizures, and/or vision  loss) | -  | increased blood pressure  in the lungs (possible  difficulty breathing  and/or heart failure)                   |    |          |
| -                                                           | hole in the bladder                                                                                  |    |                                                                                                                 |    |          |
| -                                                           | destruction of red blood  cells                                                                      | -  | blockage in the lung  (possible pain, shortness  of breath, and/or failure  to breathe)                         |    |          |
| -                                                           | decreased brain function  due to high blood  pressure                                                | -  | low red blood cell counts                                                                                       |    |          |
| -                                                           | bone destruction  (including destruction of  the jaw bone)                                           |    |                                                                                                                 |    |          |
| -                                                           | decreased blood flow to  part of the bowel  (possibly causing death  of tissue)                      | -  | abnormal hole inside the  nose                                                                                  |    |          |
| -                                                           | inflammation inside the  eye                                                                         | -  | life-threatening allergic  reaction (such as  difficulty breathing, low  blood pressure, and/or  organ failure) |    |          |
| -                                                           | blurry vision                                                                                        |    |                                                                                                                 |    |          |
| -                                                           | bleeding around the brain                                                                            | -  | increased pressure in the  eye (possible pain and/or  blurry vision)                                            |    |          |
| -                                                           | temporary stroke  symptoms                                                                           | -  | wound healing problems                                                                                          |    |          |
| -                                                           | intestinal blockage                                                                                  | -  | detached retina (possible  partial blindness)                                                                   |    |          |  
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  
Bevacizumab may rarely cause an abnormal opening that develops between one area of the body and another (for example, an abnormal connection and opening in one or more places between the trachea [breathing tube] and esophagus, which may interfere with swallowing, digestion, and/or choking). This may result in death. Rarely (in about 1-2% of patients), bevacizumab may cause bleeding in the brain in patients who have received bevacizumab for the treatment of primary brain tumors. You will be monitored for this complication and removed from the study if this were to occur. If you are taking Coumadin (warfarin) or other blood-thinning drugs, you may be at higher risk of blood clots and/or bleeding.  
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 after completing the questionnaire, you are encouraged to contact your doctor or the study chair. 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

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. Circle your choice of "yes" or "no" for each of the following optional procedures: Do you agree to have extra blood drawn for biomarker testing? YES NO  
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  
STUDY NUMBER: 16-C-0009 CONTINUATION: page 12 of 13 pages
Clinical trial: NCT01295944
Section: Procedures
Subsections: Description Of Research Study What Will Happen If I Take Part In This Research Study? Before You Begin The Study|Optional Procedures For The Study

You will have screening tests to help the doctor decide if you are eligible to take part in this study. If some of these tests have been performed within the past 14 days, they may not need to be repeated. These tests include medical history, physical exam, routine blood and urine tests, CT scan or MRI of your brain, CT scan or x-ray of your chest, an EKG and you will also complete a questionnaire about your quality of life. Tumor tissue left over from a previous procedure (such as disease diagnosis slides or tumor tissue leftover from a previous biopsy) will be collected to confirm your diagnosis and to test for biomarkers.

If you agree, blood (about 1 teaspoon) will be drawn for biomarker testing before you begin receiving the study drugs and then every 8 weeks while you are on study. Biomarkers are chemical "markers" in the blood that may be related to your reaction to the study drug. There are no benefits to you for taking part in the optional procedures. You may stop taking part at any time. The optional procedure will be performed at no cost to you. You do not have to agree to take part in the optional procedures in order to receive treatment on this study.
Clinical trial: NCT01295944
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. Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die. Carboplatin is FDA approved  
| 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)   |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
  
and commercially available for the treatment of advanced ovarian cancer. Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Bevacizumab is FDA approved and commercially available for the treatment of glioblastoma multiforme (a type of brain tumor). The use of these drugs in combination in ependymoma is investigational. At this time, this combination is only being used in research. The goal of this clinical research study is to learn if the combination of bevacizumab and carboplatin can help to control recurrent ependymoma. The safety of this drug combination will also be studied.

You are being asked to take part in this study because you have a brain or spinal cord tumor called an ependymoma that is recurrent (has returned after treatment). Clinical trials include only patients who choose to take part. Your participation in this study is entirely voluntary.
Clinical trial: NCT01295944
Section: Withdrawal from Study
Subsections: Can I Stop Taking Part In This Study?

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let your study doctor know as soon as possible so you can stop safely. If the carboplatin and bevacizumab are stopped, you can decide whether or not to let your study doctor continue to provide medical information to the organization running the study. 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. 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 the National Cancer Institute IRB 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.