Clinical trial: NCT03029611
Section: Alternatives
Subsections: What Are The Benefits?|You Have Other Choices Besides This Study.

We do not know if the combination of a vaccine (IGFBP-2) in combination with chemotherapy will help treat your cancer. We hope the information we learn will help people with ovarian cancer in the future. We do not know if this study would help you. You might get better if you receive this treatment but your condition could stay the same or even get worse. We hope the information from this study will help other people with ovarian cancer in the future.

You do not have to join this study. You are free to say "yes" or "no". Your regular medical care would not change if you decide to say "no". You have other choices for treatment. Each of these choices has risks and benefits. You should talk to your doctor or healthcare provider about these choices. Other choices include:  
- Another Research Study - No Treatment
- Comfort Care
Enrollment in this study may exclude you from other research studies.
Clinical trial: NCT03029611
Section: Confidentiality
Subsections: Protecting Privacy As An Individual And The Confidentiality Of **Personal** Information|How Is My Genetic Information Protected?

If you join this study, some people or organizations might need to look at your medical records and research records for quality assurance or data analysis. They include:
- Researchers involved with this study.  
- Institutional Review Boards (IRB), including the Fred Hutchinson Cancer Research Center IRB. An IRB is a group that reviews the study to protect the rights and welfare of research participants.  
- Fred Hutchinson Cancer Research Center, University of Washington,. - Food and Drug Administration (FDA). - Office for Human Research Protections (OHRP). - Other regulatory agencies as required.
We will do our best to keep personal information confidential. But we cannot guarantee total confidentiality. Personal information may be given out if required by law. For example, workplace safety rules may require health workers to contact you about lab tests. Or a court may order study information to be disclosed. Such cases are rare. We will not use personal information in any reports about this study, such as journal articles or presentations at scientific meetings. If you join this study, information about your participation would be made part of your permanent medical record. This information would include a copy of this consent form. If an insurance company or employer or anyone else were authorized to see the medical record, they would see a copy of this consent form.

A federal law called the Genetic Information Nondiscrimination Act (GINA) helps protect genetic information about people who join research studies. GINA restricts access to genetic information so that it cannot be used for health insurance coverage decisions. GINA prevent health insurance companies or group health plans from  
- Asking for genetic information obtained in research studies, or - Using genetic information when making decisions regarding your eligibility or premiums
GINA *does not* help or protect against genetic discrimination by companies that sell life, disability or long term care insurance.
Clinical trial: NCT03029611
Section: Duration of Study Involvement
Subsections: Initial Visit (Prior To The Start Of Your Chemotherapy)|After Completion Of Vaccinations|Long-Term Follow-Up|How Long Would You Stay In This Study?

- Informed consent conference. Review consent, have all your questions answered so you can make an informed decision to join the study or not.  
- Review your medical history and ensure you meet the eligibility criteria.  
- Physical exam which includes vital signs, medication review, and weight.  
- Clinical blood draw:
o Routine blood tests to evaluate kidney, liver, and blood system function o ANA, C3, anti-dsDNA to screen for any autoimmune disorders o Thyroid function tests to monitor for any autoimmunity specific to your thyroid o CA-125 a tumor marker for ovarian cancer
- Research blood draw  
o Up to one cup of blood will be collected for research testing so we can measure your immunity.
- Archive Tissue Collection  
o If available, we would collect tissue from your primary diagnosis to be able to compare it to your tissue from your surgery after your complete the study treatment.

After you have finished the vaccines you will enter the follow up part of the study.  
About one to two weeks after your last vaccine and before your surgery:
Physical exam which includes vital signs, and weight.  
- Clinical blood draw:  
o Routine blood tests to evaluate kidney, liver, and blood system function o ANA, C3, anti-dsDNA
o Thyroid function tests
o CA-125
- Research blood draw  
o Up to one cup of blood (depending on your blood counts) will be collected for research testing so we can measure your immunity.  
- After your surgery we will collect a piece of your tissue not needed for your clinical care for biomarker research. The tumor tissue sample we collect will only be used for research.
Approximately six months after your last vaccine, you will come back again for the following procedures:
- Physical exam which includes vital signs, and weight.  
- Clinical blood draw:
o Routine blood tests to evaluate kidney, liver, and blood system function o ANA, C3, anti-dsDNA
o Thyroid function tests o CA-125
- Research blood draw  
o Up to one cup of blood (depending on your blood counts) will be collected for research testing so we can measure your immunity.

Long-term follow-up means keeping track of someone's medical condition for a long time. If you join this study we would check with your oncologist to see how you are doing by collecting notes, labs, and imaging reports. This would occur once a year for 5 years. This information will help us learn about the long term effects of the IGFBP-2 plasmid based vaccine in combination with carboplatin/paclitaxel.

If you join this study, there will be 5 research visits to the University of Washington (UW) Clinical Research Center over a period of approximately 10 weeks for study treatment and an additional follow-up, non-treatment visit, 6 months after your last vaccine. Doctors could take you out of this study at any time. This would happen if:
- Unacceptable side effects.  
- Another illness that prevents further infusions. - They think it is in your best interest not to continue in the study. - You not able or willing to follow study procedures. - You want to enroll in another treatment trial. - You become pregnant. - The whole study is stopped.
If you withdraw from the study for any reason, previously collected information would remain in the study records and would be included in the analysis of results. This information could not be removed from the study records. We may ask you to undergo one final physical exam, which includes weight, vital signs, symptom assessment and blood collection, if applicable.
Clinical trial: NCT03029611
Section: Participant Responsibilities
Subsections: Your Responsibilities

If you join this study, you would have some responsibilities.  
- Follow the schedule of study visits and procedures. - Takes study medications as directed. - Prevent pregnancy. - Tell us about side effects.
Clinical trial: NCT03029611
Section: Participant's Rights
Subsections: Your Rights

- You do not have to join this study. You are free to say "yes" or "no". - If you get sick or hurt in this study, you do not lose any of your legal rights to seek payment by signing this form.  
- During the study, we might learn new information that you need to know.  
For example, some information may affect your health or well-being. Other information might make you change your mind about being in this study. If we learn these kinds of information, we would tell you.  
- If you join this study, you would not have to stay in it. You could stop at any time (even before you start). Your regular medical care would not change. You would have no penalty for stopping, but it would be better not to join the study if you think that you would change your mind later.  
- If you decide to drop out, we would want you to tell the study doctor. The doctor could tell you about the effects of stopping the vaccine. You and the doctor could talk about the follow-up care and testing that would help the most.  
o We would want you to come back for a follow up visit if you leave the study.  
o We would like to continue to follow your progress and any side effects you may have developed because of the vaccine.  
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.
Clinical trial: NCT03029611
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Side Effects (Risks)?|Risks Of Tetanus Diphtheria* Immunization|Risks Of Igfbp-2 Vaccination(S)|Risk Of Granulocyte-Macrophage Colony Stimulating Factor (Gm-Csf, Sargramostim)|Risk Of Generation Of An Immune Response To Normal Cells|Allergic Reaction Monitoring|What If You **Get Sick Or Hurt After You Join This Study?**

In this part of the consent form, we describe the side effects we expect from the tests and treatments in this study. Although we have given the IGFBP-2 vaccine to 25 women with a history of ovarian cancer and didn't see any serious side effects we have never given this vaccine with chemotherapy. We gave a total of 86 vaccines. If you join this study, we would tell you if we discover new side effects that could affect you.  
| Likely                            | Less likely   | Rare but serious   |
|-----------------------------------|---------------|--------------------|
| Pain                              | Bruising      | Infection          |
| Light-headedness Fatigue Fainting |               |                    |

| Likely                                                                                                                                               | Less likely                                                                                         | Rare but serious                                                                                                                                                              |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Redness, pain  and swelling at  site                                                                                                                 | Hard lump at the site                                                                               | Allergic reaction, including shortness of breath, dizziness,  a feeling of fainting, hives, and difficulty breathing caused  by swelling of the mouth, face, tongue or throat |
| Allergic reactions  such as: hives, rash,  and itching                                                                                               |                                                                                                     |                                                                                                                                                                               |
| Mild fever                                                                                                                                           | Severe allergic reaction to the vaccine may require  medication or lead to hospitalization or death |                                                                                                                                                                               |
| Decreased  appetite                                                                                                                                  | Fever > 102°F                                                                                       | Swelling, severe pain, bleeding and/or redness in the arm  where the shot was given                                                                                           |
| *If you have a history of an allergic reaction to the tetanus immunization, we will not give  you one and you can still continue to be in the study. |                                                                                                     |                                                                                                                                                                               |

| Likely                                                                           | Less likely       | Rare but serious                                                                                                                                                               |
|----------------------------------------------------------------------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pain and discomfort during  vaccine administration                               | Flu-like syndrome | Allergic reaction, including shortness of breath,  dizziness, a feeling of fainting, hives, and difficulty  breathing caused by swelling of the mouth, face,  tongue or throat |
| Muscle pain                                                                      |                   |                                                                                                                                                                                |
| Redness and tenderness  at injection site (this  usually goes away in 1-2  days) | Nausea Chills     | Severe allergic reaction to the vaccine may require  medication or hospitalization or death                                                                                    |
| Diarrhea                                                                         |                   |                                                                                                                                                                                |
| Itching at vaccine site Fatigue Headache                                         |                   |                                                                                                                                                                                |

GM-CSF is a natural substance that will be mixed and injected in very small amounts with the vaccine also known as an adjuvant. In our previous vaccine studies that used GM-CSF, patients sometimes complained of mild to moderate flu like symptoms (fever, chills, achiness, and fatigue) for 1 - 2 days after vaccination which may be related to the use of GM-CSF. The possible risks listed below are for a larger dose of GM-CSF than you will receive in this study; you will be getting a fraction of the regular GM-CSF dose.  
| Likely                                                          | Less likely                                                                                  | Rare but serious                                                |           |       |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------|-------|
| Local reactions at the site of  injection                       | Kidney and liver problems                                                                    | Fluid retention (including fluid in  lungs or around the heart) |           |       |
| Rashes                                                          |                                                                                              |                                                                 |           |       |
| Low grade fever (Less than  100.5° F)                           | Blood                                                                                        | clotting,                                                       | including | blood |
| clots in the leg veins that can  break loose and go to the lung |                                                                                              |                                                                 |           |       |
| Liver enlargement Low blood pressure                            |                                                                                              |                                                                 |           |       |
| Chills                                                          | Increased platelets, low albumin (a protein found in your blood),  increase of liver enzymes |                                                                 |           |       |
| Pain in the bones, muscles,  chest, abdomen, or joints Nausea   | Rapid or irregular heartbeat or                                                              |                                                                 |           |       |  
| Likely                                                                                                                                             | Less likely                                                                                                                                                                                                                                                                                                                                                        | Rare but serious   |           |
|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-----------|
| Vomiting                                                                                                                                           | other heart problems                                                                                                                                                                                                                                                                                                                                               |                    |           |
| Diarrhea                                                                                                                                           | Allergic                                                                                                                                                                                                                                                                                                                                                           | reaction,          | including |
| shortness of breath, dizziness, a  feeling of fainting, hives, and  difficulty breathing caused by  swelling of the mouth, face,  tongue or throat |                                                                                                                                                                                                                                                                                                                                                                    |                    |           |
| Flu-like symptoms including  fatigue, weakness, headache Decreased appetite Increased white blood cell count                                       | Worsening of pre-existing fluid  accumulation in arms and legs, in  the lungs and around the heart  that may result in breathing  problems and heart failure Neurologic syndrome called Guillain-Barré syndrome, where a  person's own immune system  damages their nerve cells,  causing muscle weakness and  sometimes paralysis Temporary loss of consciousness |                    |           |

It is unknown whether generating an immune response to this specific protein on your cells will have any effect on normal cells.  
We will be monitoring you closely for signs of immune damage to normal cells. We will be looking for diarrhea, development of any unusual rashes and changes in your liver, kidney, and blood function through blood tests.  
Medicine may be administered if you develop any autoimmune symptoms.  
A severe autoimmune reaction could cause death.  
Likely Less likely Rare but serious  
None Skin rashes  
| A severe autoimmune reaction  could cause death   |
|---------------------------------------------------|
| Diarrhea                                          |

Severe allergic reactions are not common, but they do occur. If they occur, they tend to happen within an hour or so of exposure to the substance causing the allergy. Because of this rare risk, we will watch you in the clinic for a minimum of one hour after you receive each vaccine and booster vaccine to make sure you have no immediate side effects or allergic reactions. *Please allow time in your* schedule for this 60 minute monitoring. Side effects may be mild or very serious. Medicines could be given to help lessen side effects. In some cases, side effects can last a long time or never go away. There also is a risk of death.

For a life threatening problem, call 911 right away or seek help immediately. Contact your study doctor when the medical emergency is over or as soon as you can. For all other medical problems or illness related to this research, immediately contact Dr. John B. Liao. His team will treat you or refer you for treatment. You or your health insurance will have to pay for the treatment. There are no funds to pay you for a research-related injury, added medical costs, loss of a job, or other costs to you or your family. State or national law may give you rights to seek payment for some of these expenses. You do not waive any right to seek payment by signing this consent form. You or your insurer will be billed for treatment of problems or complications that result from your condition or from standard clinical care. You would not lose any legal right to seek payment for treatment if you sign this form.
Clinical trial: NCT03029611
Section: Procedures
Subsections: Vaccinations

Vaccinations will be approximately given two weeks after each chemotherapy visit for a total of 3 vaccine visits. Before each vaccine you will have:  
- Physical exam which includes vital signs, weight and a urine pregnancy test (if applicable)
o If you are pregnant you will not be able to receive the study vaccine..  
- Medication review - Side effect(s) review
You must stay in the clinic for at least one hour after each vaccine to monitor you for any allergic reaction.  
Prior to the first vaccine you will have a tetanus vaccination if you haven't had one in the last 6 months. This will help us measure your overall immune response.
Clinical trial: NCT03029611
Section: Purpose of Research
Subsections: Why Are We Doing This Study?

We are doing this study to examine if giving the vaccine along with your chemotherapy enhances the effectiveness of the chemotherapy. The vaccine targets IGFBP-2. IGFBP-2 is a protein found in the blood and tumor cells of most women who have been diagnosed with ovarian cancer. Too much IGFBP-2 has been associated with more invasive disease. One possible way to get rid of IGFBP-2 on tumor cells is simply to encourage your own immune system to generate an immune response against the tumor cells expressing IGFBP-2. Immunizing you with a vaccine against IGFBP-2 may do this. The vaccine is made up of DNA which is a natural substance in every living organism that helps make the proteins that cause cells in your body to function. The DNA we use is isolated from a bacteria and a portion of the IGFBP-2 protein code (DNA) is inserted. The IGFBP-2 vaccine has previously been tested as a vaccine alone. The vaccine used in this study is not approved by the Food and Drug Administration (FDA) for commercial use; however, the FDA has permitted its use in this research study. What research tests, procedures, and treatments are done in **this study?** If you join this study, we would do these tests and procedures:
Clinical trial: NCT03029611
Section: Voluntary Participation
Subsections: Would We Pay You If You Join This Study?

There is no payment for being in this study. You will be given the option of receiving pre-paid parking vouchers for your research visits to the University of Washington Medical Center.