Clinical trial: NCT01730118
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 and maximize your quality of life. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.
Clinical trial: NCT01730118
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 Institutes of Health Intramural Institutional Review Board The study Sponsor, NCI Center for Cancer Research, or their agent(s)
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 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: NCT01730118
Section: Duration of Study Involvement
Subsections: How Many People Will Take Part In This Study?|This Consent Document Has Been Approved For Use From November 05, 2018 Through November **12, 2019.**

The total number of patients we are seeking to enroll in this study is up to 65. There are two parts to this study. Part I seeks to enroll 30 subjects and Part II seeks to enroll another 30 subjects.

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: NCT01730118
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.
Clinical trial: NCT01730118
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?|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

Because this is the first study of the AdHER2 DC vaccine in people, it is not known what the side effects will be. Since this is a vaccine, it is highly likely that you will have a reaction at the site where the vaccine is injected under the skin. Because trastuzumab targets HER2 and is known to be associated with cardiac toxicity, we are monitoring patients in this study very closely since we are giving them a vaccine that will induce their own immune system to make antibodies that target HER2. There have been many studies investigating different types of HER2 therapeutic cancer vaccines and there have been no known reports of cardiac toxicity to date with these agents. Nevertheless, your heart will be tested before you receive the investigational AdHER2 DC and at regular intervals during the study as described previously. If you have a heart problem that would put you at risk for these side effects, you will not be able to join the study. The test drug will be stopped if you develop a heart problem during the study.

The aim of this study is to see if this experimental AdHER2 DC vaccine will stimulate your immune system and cause your tumor to shrink. We do not know if you will receive personal, medical benefit from taking part in this study. Your tumor may shrink, stay the same or get larger. From pre-clinical animal studies, we know that mice treated with the AdHER2 vaccine had tumors get larger for a brief period of time before they subsequently shrunk and disappeared. Because we have no information about this vaccine in humans, we are unable to predict whether the autologous AdHER2 DC vaccine will have an effect on your cancer and 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 and are receiving immune-based therapies and cancer vaccines.
Clinical trial: NCT01730118
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Before You Begin The Study|During The Study|Apheresis:|Vitamin D Testing:

You will need to have the screening examinations, tests or procedures to find out if you can take part in the study. Some of these examinations, test or procedures will be repeated during the study to assure your safety and to assess your response to AdHER2 DC vaccination. Screening tests and scans must be done within 2 weeks before enrolling in the study. The tests will check your medical history and overall health, determine if your tumor is HER2 positive, and measure the extent of your disease with a CT scan and bone scan. If you are a female with the ability to get pregnant, the study doctors must also confirm that you are not pregnant. We will also request medical information from your local doctor. Your heart will be tested before you receive the AdHER2 DC vaccine and regularly throughout the study. If you have a heart problem that would put you at risk for cardiac side effects you will not be able to join the study. The AdHER2DC vaccine will be stopped if you develop a heart problem during the study. A screening visit will include:  
Complete medical history and physical exam Blood tests Pregnancy test for women CT scan of the brain, chest, abdomen and pelvis and a bone scan 2D Echocardiogram (echo)

After you have been found eligible for this study you will be scheduled for apheresis. During the apheresis procedure circulating peripheral blood cells will be collected; these cells will be processed and used to make your own custom made AdHER2 DC vaccine. A large number of cells are required to ensure that we have sufficient cells to make at least 5 vaccines; that is why we use the apheresis procedure. Apheresis is explained below.

The procedure for obtaining certain types of blood cells through apheresis is a very common procedure that is done routinely here in the Clinical Center with very few risks. Apheresis requires you to have a needle placed in your arm where the blood can be removed from you and circulated through a cell separator machine (a machine that divides whole blood into red cells, plasma (the serum part) and circulating cells (that includes lymphocytes and monocytes). The circulating blood cells are removed and the plasma and red cells are returned to you through another needle in your other arm. The procedure takes approximately 1 to 3 hours to complete. The primary purpose of apheresis is to collect a sufficient number of cells in order to make all the vaccines you will be given during the study. However, if not enough cells are collected to make a minimum of 5 vaccines, apheresis may be repeated if the investigator thinks it's necessary. Another purpose of apheresis is to allow the investigator to collect a sufficient amount of immune cells to measure the immune response to the vaccine. This testing will provide no benefit to you and is part of the experimental portion of this research study. Patients do not need to be hospitalized for the apheresis procedure. The apheresis will be done in the apheresis clinic in the Department of Transfusion Medicine (Blood Bank) in the NIH Clinical Center and is carried out by trained nurses supervised by Blood Bank physicians.

The exact role that Vitamin D deficiency plays in cancer has been controversial; but we do know that Vitamin D plays a critical role in cellular and immune functions within the body. Included in your blood work will be a Vitamin D level; if your Vitamin D levels are found to be deficient (low) you will be asked to start an oral supplement of Vitamin D. Your Vitamin D levels will be monitored throughout the study. We will repeat a CT scan immediately before you are scheduled to receive your first dose of AdHER2 DC vaccine to make sure you do not have rapidly progressive disease. Patients documented to have rapidly progressive disease at Week 0 will be removed from the study and not be eligible to receive the AdHER2 DC vaccine. With each visit you will have blood draws and a physical exam, you will be asked about any side effects or illnesses you may have had. You will also be asked if you took any medicine at each visit. You will be given a study calendar with the visits and test or exams listed. You will receive your last vaccine at week 24 but you will continue to have monitoring visits with blood draws, physical exams, cardiac examinations, scans, and clinic visits.  
| Study Visit and Procedure Calendar  Study  Screen/ Wk  Wk  Wk  Wk Wk  Wk  Wk  Wk  Wk  Wk  Wk  Wk  Wk  Wk  Wk  Wk  Procedures Baseline 0 4 8 12 16 20 24 28 32 36 40 48 60 76 100 124 Clinic Visit for  Medical  History,  Physical Exam, Vital Signs, Lab  Draws for  Monitoring and  Research  x x x x x x x x x x x x x x x x x Informed  Consent x HER2/neu Path  Confirm x Urinalysis x x x x x Apheresis x AdHER2 DC x x x x xPATIENT IDENTIFICATION CONTINUATION SHEET for either: NIH-2514-1 (07-09) NIH-2514-2 (10-84)   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
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  
| VACCINE  AdHER2 DC  Vaccine Report   | x   | x   | x   | x   | x   |    |    |    |    |    |    |
|--------------------------------------|-----|-----|-----|-----|-----|----|----|----|----|----|----|
| Card CT Brain  (Screening            | x   | x   | x   | x   | x   | x  | x  | x  | x  |    |    |
| only) CT Torso Bone Scan1            | x   | x   | x   | x   | x   | x  | x  | x  | x  |    |    |
| 2-D ECHO2                            | x   | x   | x   | x   | x   | x  | x  | x  | x  | x  | x  |  
1 Bone scans after you complete the treatment are optional and may be repeated only if clinically indicated 2 after you complete your treatment, we will ask your doctor for ECHO reports to make sure your heart is properly working. Birth Control If you are a woman who is breast feeding or pregnant, you cannot take part in the study because we don't know how this investigational vaccine would affect your baby or your unborn child. If you are a woman who can become pregnant, or are the partner of a woman who can become pregnant, you will need to practice an effective form of birth control before starting study treatment, during study treatment, and for 3 months after you finish study treatment. If you think that you or your partner is pregnant, you should tell your study doctor or nurse at once. Effective forms of birth control include:
abstinence intrauterine device (IUD) hormonal [birth control pills, injections, or implants] tubal ligation vasectomy
Clinical trial: NCT01730118
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

This study is being conducted in patients with HER2/neu expressing tumors. HER2 stands for Human Epidermal Growth Factor Receptor 2. HER2/neu (HER2) is a tumor protein over expressed in up to 25-30% of breast cancers and in other cancers such as ovarian, cervical, colon, gastric, non-small cell lung (NSCLC), renal cell, bladder, sarcoma, prostate and other cancers. Research has shown that tumors that over express HER2 can be associated with a more aggressive cancer, a higher recurrence rate and a reduced survival rate. If you have breast cancer that expresses HER2, you may have previously been treated with FDA approved agents such as Herceptin (also known as trastuzumab), Tykerb (also known as lapatinib), Perjeta (also known as pertuzumab), Kadcyla (also known as ado-trastuzumab) or investigational agents such as MGAH22 that specifically target the HER2/neu tumor protein. This research study involves the use of a cancer vaccine that expresses human HER2 and is designed to stimulate your immune system to recognize HER2. The vaccine is a custom-made vaccine using your own immune cells (dendritic cells). Dendritic cells (DCs) are derived from immune cells that circulate in the blood called monocytes. The monocytes are collected from your blood during a process called apheresis that you will undergo one time at the beginning of this study. The autologous AdHER2 DC vaccine being used in this study is investigational and has not been approved by the U.S. Food and Drug Administration (FDA). The adenoviral vector and adenoviral DC vaccine has been studied in mouse models of breast cancer and was shown to shrink large established tumors. This is the first time that it is being tested in humans to see if it is safe and whether it may be a potential treatment for HER2 positive cancers. The main purpose of this study is to determine the safety of autologous AdHER2 DC vaccination and to determine the risk, if any, for cardiac toxicity.

We invite you to participate in this research study because you have a recurrent, metastatic solid tumor such as breast, ovarian, cervical, colon, gastric or gastroesophageal, non-small cell lung, prostate or bladder cancer, malignant soft tissue and bone tumor or other cancer that overexpresses HER2 or you have HER2 positive bladder cancer and have received primary treatment for your cancer and you are at high risk of recurrence.
Clinical trial: NCT01730118
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 comes back 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 you develop another 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 your doctor decides to end the study 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 the Study Sponsor 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.