Clinical trial: NCT02810418
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:  
x 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.  
x NIH Intramural 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. Certificate of Confidentiality 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 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:
x will be used for auditing or program evaluation internally by the NIH; or  
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  
x must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
x is necessary for your medical treatment and you have consented to this disclosure; x 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: NCT02810418
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:  
x 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.  
x 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.  
x Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
x Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT02810418
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

The following study procedures may have risks and cause discomfort while you participate on this study: Blood draws There is the risk of slight pain, bruising or infection when your blood is drawn. Drawing blood may cause some people to faint.

The aim of this study is to find a safe dose as well as 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. If you are eligible and receive treatment, 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.
Clinical trial: NCT02810418
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

LMB-100 is an investigational agent, meaning that it has not been approved by the US Food and Drug Administration. It is a type of manufactured protein which is similar to protein normally produced by your body. LMB-100 is attracted to the mesothelin protein, which is present on the  
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 (3)  
surface of many different tumors. The mesothelin protein is found in only a very small number of normal tissues. After binding to the mesothelin on tumors, LMB-100 can then attack and kill cancer cells.  
In this study, we will test different schedules of LMB-100 dosing and different doses of LMB100 in combination with nab-paclitaxel, an FDA approved drug. In one part of the study, the part in which you may be participating, we are testing a safe dose of LMB-100 alone. This is the Arm B1, continuous infusion single agent lead-in portion of the study. In order to be eligible to participate in this portion of the study, unless you have pancreatic cancer or a type of mesothelioma called epithelioid, we need to test whether your tumor cells have mesothelin. Please be aware that the test that will be used in this study determine the mesothelin status of your tumor is experimental (Investigational Device) and is limited by United States law to experimental use. Experimental means that the test is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies.
Clinical trial: NCT02810418
Section: Withdrawal from Study
Subsections: Stopping Participation

Your doctor may decide to remove you from the study for the following reasons:
x if you are found to be ineligible You can stop taking part in the study at any time. 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 collaborators 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.