Clinical trial: NCT01441115
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:
- 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: NCT01441115
Section: Duration of Study Involvement
Subsections: During The Study

Everyone enrolled in the study will receive the same dose of radiation therapy (3 Gy per daily fraction) Monday through Friday, to a total dose of 30 Gy delivered over two weeks. On this study, one or two sites may be treated. In addition to the radiation therapy, a total of 5 groups of 3-6 patients each will receive increasing doses of ECI301, until we find the highest dose that can be given safely. This is called "dose escalation". Ask your doctor what dose of ECI301 you will be receiving. Before starting treatment, you will have the option of consenting to a biopsy of the site with that will receive radiation. During 2, the ECI301 infusion will be given to you in the outpatient clinic or the inpatient unit about one to two hours after your radiation treatment Monday through Friday. Your radiation treatment will be completed at the end of week 2.  
At week 3, you will have the option of consenting to a second biopsy of the site that received radiation and a biopsy of another site of cancer that did not receive radiation. Study Chart  
| Day             | What to do and what will happen to you                                                                                                                                                                                                                              |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Screening/      | Get routine blood tests; urine tests will be done, including the collection of urine for 24 hours. If you                                                                                                                                                           |
| Baseline        | are female you will be tested for pregnancy. Provide a history of how you feel and undergo a physical examination by the research team's Health  Care Provider. Research blood and a tumor biopsy (optional). EKG, CT Scan, MRI, x-rays and ultrasound may be done. |
| Week 1          | Provide a history of how you feel and undergo a physical examination by the research team's Health                                                                                                                                                                  |
| (Monday-Friday) | Care Provider.  Research blood samples will be taken (Monday). Receive radiation to the sites that your doctor has chosen (Monday-Friday). Report any side effects to the research team.                                                                            |  
PATIENT IDENTIFICATION **CONTINUATION SHEET for either:**  
NIH-2514-1 (10-84) NIH-2514-2 (10-84) P.A.: 09-25-0099  
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 11-C-0248 CONTINUATION: page 4 of 10 pages  
| Week 2                 | Provide a history of how you feel and undergo a physical examination by the research team's Health                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Monday-Friday)        | Care Provider.  Get routine blood tests; urine test will be done (Monday and Friday). Research blood samples will be taken (Monday and Friday). A blood sample will be taken to test the amount of ECI301 in your blood (Monday, Tuesday, Thursday  and Friday). On the Monday and Thursday , blood samples will be drawn at 0, 15 and 30 minutes,  and 1, 2, 4, 6, 8, and 24 hours after ECI 301 is givenand just before the final dose is given  EKG (Monday and Friday) Receive radiation to the sites that your doctor has chosen (Monday-Friday). Receive ECI301 in the vein (IV) in the day hospital approximately 1 to 2 hours after completion of  radiation (Monday-Friday). Report any side effects to the research team. |
| Week 3                 | Return to the NIH clinic to see your doctor. Provide a history of how you feel and have a physical  exam by your Health Care Provider.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| Follow-up              | Get routine blood tests; urine test will be done. Research blood and a tumor biopsy (optional).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| Week 4                 | Return to the NIH clinic to see your doctor. Provide a history of how you feel and have a physical  exam by your Health Care Provider.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| Follow-up              | Get routine blood tests; urine test will be done. Research blood and a tumor biopsy (optional).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| Week 6                 | Return to the NIH clinic to see your doctor. Provide a history of how you feel and have a physical  exam by your Health Care Provider.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| Follow-up              | Get routine blood tests.  Collect urine for 24 hours. CT Scan, MRI, x-rays and ultrasound may be done.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| Week 12                | Return to the NIH clinic to see your doctor. Provide a history of how you feel and have a physical  exam by your Health Care Provider.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| Follow-up              | Get routine blood tests. CT Scan, MRI, x-rays and ultrasound may be done.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| 6 months               | Return to the NIH clinic to see your doctor. Provide a history of how you feel and have a physical                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| Follow-up              | exam by your Health Care Provider. Get routine blood tests.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
| PATIENT IDENTIFICATION | CONTINUATION SHEET for either: NIH-2514-1 (10-84) NIH-2514-2 (10-84) P.A.: 09-25-0099                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |  
| NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study   |
|----------------------------------------------------------------------------------|  
STUDY NUMBER: 11-C-0248 CONTINUATION: page 5 of 10 pages
Clinical trial: NCT01441115
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 even 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.  
PATIENT IDENTIFICATION **CONTINUATION SHEET for either:**  
NIH-2514-1 (10-84) NIH-2514-2 (10-84) P.A.: 09-25-0099
Clinical trial: NCT01441115
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?** Eci301|Late Side Effects Of Radiation|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

You may have side effects while you are taking the study drugs. Everyone taking part in the study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen, so it is important to report any changes that you notice, even if your study team does not ask specifically about them. Side effects may be mild or severe. Your study team will give you medicines to help lessen side effects. Many side effects go away with those medicines and others may go away soon after you stop the study drugs. In some cases, side effects can be serious, long lasting, or may never go away. There are no known long-lasting side effects from ECI301. If new information about side effects becomes available, we will make you aware of this new information. This is the first time that the drug ECI301 has been given to humans. This means that ECI301 has never been tested in humans before this study. The side effects of ECI301 infusions in man are unknown. Studies in animals suggest that ECI301 should be safe at the doses we will use in this protocol. It is possible that ECI301 will make your cancer more sensitive to radiation therapy. It is also possible that ECI301 will help your body's immune system recognize and destroy the cancer at sites that have not been treated with radiation  
PATIENT IDENTIFICATION **CONTINUATION SHEET for either:**  
NIH-2514-1 (10-84) NIH-2514-2 (10-84) P.A.: 09-25-0099  
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 11-C-0248 CONTINUATION: page 6 of 10 pages therapy. This could result in longer lasting relief of your symptoms or a decrease in the size of your tumor. It is also possible that ECI301 could increase the effects of radiation therapy on normal tissues that are in the treatment area which could result in inflammation (redness or swelling). The expected discomforts of infusions of ECI301 are the same as those to be expected from other infusions. These include pain and discomfort from a vein being punctured.

Some side effects of radiation can happen many months or years after treatment. It is impossible to predict who will develop long-term side effects. Your doctor will discuss these risks with you.

The aim of this study is to see if this experimental treatment will cause your cancer to shrink. We hope that you will get personal medical benefit from taking part in this study, but we cannot be certain. These potential benefits could include shrinking your cancer or decreasing your symptoms, such as pain, that are caused by the cancer. Because there is not much information about ECI301'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.
Clinical trial: NCT01441115
Section: Procedures
Subsections: What Will Happen If You **Take Part In This Research Study?** Before You Begin The Study

All research studies have specific criteria for entry to allow for valid interpretation of the study results and safety of participants, known as eligibility criteria. Before you begin this study you will need to have the following exams and tests to make sure you are eligible for this study. The exams and tests are part of regular cancer care and may be done even if you do not join the study. It is possible that if you recently had some of these tests, they may not need to be repeated.  
- History and physical examination, including vital signs (height, weight, blood pressure, heart rate, temperature, breathing rate).  
- Standard blood tests to measure: your liver and kidney function, white blood cells, red blood cells and platelets, your blood's ability to clot, your blood sugar and blood electrolytes. If you are a woman who is able to get pregnant, you will also be tested for pregnancy.  
- Detailed measurement of your kidney function. This will require you to collect your urine for 24 hours.  
- Scans, CT scan, ultrasound, MRI and X-rays of your tumors to measure your disease within 3 weeks of your first dose of ECI301.  
- HIV Testing: As part of this study, we will test you for infection with the human immunodeficiency virus (HIV),
the virus that causes AIDS. If you are infected with HIV you will not be able to participate in this study. We will tell you what the results mean, how to find care, how to avoid infecting others, how we report newly diagnosed HIV infection, and the importance of informing your partners at possible risk because of your HIV infection.  
- Hepatitis B and C screening. - Electrocardiogram to measure your heart function
- Confirmation of diagnosis and stage of disease.  
If you meet the eligibility criteria for this study you will be offered the option to participate.  
PATIENT IDENTIFICATION **CONTINUATION SHEET for either:**  
NIH-2514-1 (10-84) NIH-2514-2 (10-84) P.A.: 09-25-0099  
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 11-C-0248 CONTINUATION: page 3 of 10 pages
Clinical trial: NCT01441115
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

In this study we will be giving an experimental anti-cancer drug, called ECI301, with radiation therapy to patients with metastatic or locally advanced cancer. ECI301 is an experimental drug that has not yet been studied in humans and is not approved by the U.S. Food and Drug Administration (FDA). Radiation therapy is one way to treat body sites where cancer has spread. In this study, radiation therapy will be given to one or two areas of cancer that are causing pain or might cause an emergency if left untreated.  
The radiation therapy is not experimental and it is given over two weeks in the standard way that it would be given to those not on a study. The difference between this study and standard treatment is that the experimental drug, ECI301 will be given for two weeks during radiation therapy and for an additional week after radiation therapy. ECI301 is manmade and is similar to a protein residing inside the human body. ECI301 affects a type of white blood cells (effector cells). It is possible that ECI301 will make your cancer more sensitive to radiation therapy. It is also possible that ECI301 will help your body's immune system recognize and destroy the cancer at sites that have not been treated with radiation therapy.  
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)  
| NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study   |
|----------------------------------------------------------------------------------|  
STUDY NUMBER: 11-C-0248 CONTINUATION: page 2 of 10 pages The purpose of this study is to evaluate the potential benefits and side effects of ECI301 when given with radiation therapy. This will help us learn the best dose of ECI301 to give with radiation therapy. In addition, this study will also help us learn how long ECI301 remains in the human body and if ECI301 can change cancers outside of the area treated with radiation therapy.

You are being asked to participate because you have either metastatic or locally advanced cancer, and your doctor has determined that you would benefit from radiation therapy.
Clinical trial: NCT01441115
Section: Voluntary Participation
Subsections: Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study|Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study|Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study|Nih 2514-2, Minor Patient'S Assent To Participate In A Clinical Research Study

STUDY NUMBER: 11-C-0248 CONTINUATION: page 7 of 10 pages
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.

STUDY NUMBER: 11-C-0248 CONTINUATION: page 8 of 10 pages The biopsies to be performed are exclusively for research purposes and will not benefit you. It might help other people in the future. Even if you sign "yes" to have the biopsy you can change your mind at any time. Please read each sentence below and think about your choice. After reading each sentence, circle and initial the answer that is right for you. The decision to participate in this part of the research is optional, and no matter what you decide to do, it will not affect your care. I agree to have the tumor biopsies for the research tests in this study. Yes No Initials_________

STUDY NUMBER: 11-C-0248 CONTINUATION: page 7 of 10 pages
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.

STUDY NUMBER: 11-C-0248 CONTINUATION: page 8 of 10 pages The biopsies to be performed are exclusively for research purposes and will not benefit you. It might help other people in the future. Even if you sign "yes" to have the biopsy you can change your mind at any time. Please read each sentence below and think about your choice. After reading each sentence, circle and initial the answer that is right for you. The decision to participate in this part of the research is optional, and no matter what you decide to do, it will not affect your care. I agree to have the tumor biopsies for the research tests in this study. Yes No Initials_________
Clinical trial: NCT01441115
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:
- if he/she believes that it is in your best interest - if your disease gets worse during treatment - if you have side effects from the treatment that your doctor thinks are too severe - if new information shows that another treatment would be better for you If this happens, you will be informed of the reason therapy is being stopped.  
You can choose to 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 both the study doctor and your regular doctor first.