Clinical trial: NCT03468075
Section: Alternatives
Subsections: What Other Treatment Options Are There?

Before you decide whether or not to be in this study, your doctor will discuss the other options that are available to you. Instead of being in this study, you could receive the standard treatment for your disease or opt to be in a different clinical trial.
Clinical trial: NCT03468075
Section: Confidentiality
Subsections: What About Confidentiality?|Will My Health Information Be Used During This Study?

We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people such as those indicated below may become aware of your participation in this study and may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you.  
- federal government regulatory agencies,
- the U.S. Food and Drug Administration (FDA)
- The Holden Comprehensive Cancer Center
- auditing departments of the University of Iowa, and - the University of Iowa Institutional Review Board (a committee that reviews and approves research studies) To help protect your confidentiality, we will we will keep study documents and binders in locked offices.  
  
Electronic information will be stored on password protected computers. Where feasible, we will use a research ID to minimize using your name. All printed documents are stored in a locked office at the hospital. Any blood samples that we take for research testing are dated and named using your Research ID. They are also stored at the University in a locked room. If we write a report or article about this study or share the study data set with others, we will do so in such a way that you cannot be directly identified. The University of Iowa Hospitals and Clinics generally requires that we document in your medical record chart that you are participating in this study. The information included in the chart will provide contact information for the research team as well as information about the risks associated with this study. We will keep this Informed Consent Document in our research files; it will not be placed in your medical record chart. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

The Federal Health Insurance Portability and Accountability Act (HIPAA) requires your healthcare provider to obtain your permission for the research team to access or create "protected health information" about you for purposes of this research study. Protected health information is information that personally identifies you and relates to your past, present, or future physical or mental health condition or care. We will access or create health information about you, as described in this document, for purposes of this research study and for your treatment. Once your healthcare provider has disclosed your protected health information to us, it may no longer be protected by the Federal HIPAA privacy regulations, but we will continue to protect your confidentiality as described under "Confidentiality." We may share your health information related to this study with other parties including federal government regulatory agencies, the University of Iowa Institutional Review Boards and support staff, the U.S. Food and Drug Administration, and the Data and Safety Monitoring Board of the Holden Comprehensive Cancer Center. You cannot participate in this study unless you permit us to use your protected health information. If you choose not to allow us to use your protected health information, we will discuss any non-research alternatives available to you. Your decision will not affect your right to medical care that is not research-related. Your signature on this Consent Document authorizes your healthcare provider to give us permission to use or create health information about you. Although you may not be allowed to see study information until after this study is over, you may be given access to your health care records by contacting your health care provider. Your permission for us to access or create protected health information about you for purposes of this study has no expiration date. You may withdraw your permission for us to use your health information for this research study by sending a written notice to:
Varun Monga, MBBS University of Iowa Hospitals & Clinics 200 Hawkins Drive, C21 GH Iowa City IA 52242  
  
However, we may still use your health information that was collected before withdrawing your permission. Also, if we have sent your health information to a third party, such as the study sponsor, or we have removed your identifying information, it may not be possible to prevent its future use. You will receive a copy of this signed document.
Clinical trial: NCT03468075
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

If you agree to take part in this study, your involvement will last for approximately 2-1/2 years. For the first 6 months, you will receive treatment during weeks 1, 2 and 3 of each 4-week cycle. Ascorbate infusions will occur on Days 1, 2, 8, 9, 15 and 16. Gemcitabine infusions will occur on Days 1, 8 and 15. Each visit will last between 3 and 6 hours. After your treatment has finished, you will have followup visits every 3 months until progression of your cancer.
Clinical trial: NCT03468075
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of This Study?|Intravenous Ascorbate (Vitamin C) Serious|Mild|Risks From Drawing Blood|Less Likely Side Effects - Itching (<1%)|What If I Am Injured As A Result Of This Study?

You may experience one or more of the risks indicated below from being in this study. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.

- Diarrhea <10% - Nausea or vomiting <5% - Kidney stones <5% - Precipitation of cystine, oxalate or urate crystals in the kidney resulting in kidney damage or failure <1%

- Dry mouth/thirst (>35%) - Headache <5% - Abdominal pain <5% - Fatigue <5% - Facial flushing <5% - Sweating <5% - Weakness <5% - Injection site irritation may occur <2% - Faintness or dizziness may occur with rapid IV administration <5% - Ascorbic acid infusion may leak outside the vein, resulting in pain and irritation at the site <2%

Drawing blood may cause pain, bruising, bleeding or infection at the site of the needle stick. Care will be taken to avoid these complications.  
  
Risks associated with standard chemotherapy

- Constipation (<1%) - Loss of muscle or nerve function which may cause weakness or numbness (similar to having your hand or leg "fall asleep," and which may be associated with some clumsiness of movement) (10%)
- Allergic reaction (<1%) - Fluid collection (including swelling of the legs and/or arms), and narrowing of the air passages of the lung(20%)
- Radiation recall (changes to the skin in previously irradiated areas) (<1%) - Inflammation of the lung tissue (pneumonitis) (<1%) - Hyperglycemia (<1%)  
- Cardiac dysfunction (<1%) - Encephalopathy (a disease that can damage your brain) (<1%) - Renal toxicity (<1%)

- If you are injured or become ill from taking part in this study, medical treatment is available at the University of Iowa Hospitals and Clinics.  
- The University of Iowa does not plan to provide free medical care or payment for treatment of any illness or injury resulting from this study unless it is the direct result of proven negligence by a University employee.  
- If you experience a research-related illness or injury, you and/or your medical or hospital insurance carrier will be responsible for the cost of treatment.
Clinical trial: NCT03468075
Section: Procedures
Subsections: What Will Happen During This Study? Before You Begin The Study Treatment|During Your Study Treatment|After Your Study Treatment

You will need to have some tests done to find out if you can continue to be in the study. Some of these tests are part of regular cancer care and may be done even if you do not join the study treatment. If you have had some of them recently, they may not need to be repeated. This is up to your doctor.  
- Physical examination including vital signs. - ECOG performance status will be assessed by asking you a few questions. This is a scale used to assess how your disease affects the activities of daily living.  
- Electrocardiogram (ECG) and echocardiogram or nuclear medicine heart function test to check the function of your heart.  
- Blood will be taken to determine blood counts, kidney function, liver function, electrolyte levels, and levels of an enzyme in your blood called G6PD. The result of the G6PD test will be added to your medical record.  
- Urinalysis - Pregnancy test (if you are a woman of child-bearing potential). The results of this test will also be added to your medical record.  
- CT scan of the chest, abdomen and pelvis.  
- MRI of your arms and/or legs if your tumor is located there. - You will have blood drawn for research labs prior to the test dose of ascorbate to check the oxidative stress markers in your blood.  
- A 15 gram test dose of ascorbate via IV infusion will be administered. If you do have a serious side effect or a significant medical event in the opinion of the study doctor, you will not continue in the study. Your study doctor will let you know if you are unable to continue in the study.
High dose ascorbate may interfere with finger-stick blood glucose readings. If you are using a finger-stick glucometer, you must discuss this with the study doctor. You may not be able to participate in this study.

If the tests show you can proceed, you will begin receiving infusions of high-dose ascorbate and gemcitabine.  
- You will visit your doctor for a physical examination, vital signs and standard-of care labs on Days 1, 8, and 15 of each 28-day cycle, prior to each high-dose ascorbate infusion. You will also return  
  
  
on Days 2, 9 and 16 for a high-dose ascorbate infusion. Each ascorbate infusion will take approximately 2 hours to complete. You will have 6 cycles of treatment with high-dose ascorbate. You may be able to receive additional cycles of high-dose ascorbate, if you are responding well to the drug, and if your doctor thinks it's in your best interest.  
- You will have an infusion of gemcitabine on Days 1, 8 and 15 of each 28-day cycle, after the infusion of high dose ascorbate. Each infusion will last approximately 90 minutes. You will have 6 cycles of treatment with gemcitabine. You may be able to receive additional cycles of gemcitabine, if you are responding well to the drug, and if your doctor thinks it's in your best interest.  
- You will have blood drawn for research labs on several occasions, sometimes before your infusion, and sometimes after your infusion. This is to check the ascorbate levels and oxidative stress markers in your blood.  
- At the end of Cycles 2, 4 and 6 you will have a CT of the chest, abdomen and pelvis and an MRI of your arms and/or legs if your tumor is located there.  
- During your study treatment, you will have 6 visits to the clinic each month, and one extra visit every other month for scans.

- You will have a follow-up appointment in the Holden Comprehensive Cancer Center about 28 days after your final ascorbate treatment. It is very important you keep this appointment. You will have a physical exam, blood drawn for standard-of-care labs and a CT scan and/or MRI of your tumor.  
- Your next follow up appointments will be scheduled every 3 months until progression of your cancer is seen. At these visits you will have a physical exam, blood drawn for standard-of-care labs (first followup visit only) and for research purposes (first followup visit only). You will have a CT scan and/or MRI only if your doctor thinks it's needed. These tests are normal for your cancer care. It is important that you keep these appointments so we know how you are doing. We will also speak with you to see if there are any side effects from the ascorbate.
Clinical trial: NCT03468075
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

This is a research study. We are inviting you to participate in this research study because you have sarcoma in the soft tissue or bone that can't be removed by surgery or has returned after chemotherapy. The purpose of this research study is to see if high dose ascorbate (Vitamin C) in combination with gemcitabine, a standard chemotherapy for sarcoma, will reduce the size of your tumor. We hope that high doses of ascorbate together with chemotherapy would work better in killing the cancer cells, while minimizing the side effects from chemotherapy. High dose ascorbate is not approved by the U.S. Food and Drug Administration for any cancer. It is considered investigational for patients with soft tissue and bone sarcomas, which means that it has not been approved by the U.S. Food and Drug Administration.
Clinical trial: NCT03468075
Section: Voluntary Participation
Subsections: Is Being In This Study Voluntary?

Taking part in this research study is completely voluntary. You may choose not to take part at all. If you decide to be in this study, you may stop participating at any time. If you decide not to be in this study, or if you stop participating at any time, you won't be penalized or lose any benefits for which you otherwise qualify.
Clinical trial: NCT03468075
Section: Withdrawal from Study
Subsections: What If I Decide To Drop Out Of The Study?|Can Someone Else End My Participation In This Study?

If you decide to leave the study early, we will ask you to discuss your cancer treatment plans with your doctors so that you continue to receive clinical treatment for your cancer. We will also:  
- need to take blood samples to make sure your kidneys, liver, and bone marrow are functioning
- meet with you to discuss the side effects, if any, you had from ascorbate Will I Receive New Information About the Study while Participating?
If we obtain any new information during this study that might affect your willingness to continue participating in the study, we'll promptly provide you with that information.

Under certain circumstances, the researchers or study sponsor might decide to end your participation in this research study earlier than planned. This might happen because you have a bad reaction to the study drug or because in our judgment it would not be safe for you to continue.