Mesenchymal Stem Cells (MSC) for Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical research study is to find the highest tolerable dose of human
      mesenchymal stem cells with interferon beta (MSC-INFb) that can be given to patients with
      ovarian cancer and to test the safety of the MSC-INFb.

      This is an investigational study. MSC-INFb infusions for ovarian cancer is investigational.

      Up to 21 patients will take part in this study. All will be enrolled at MD Anderson.
    

Detailed description: 
      MSCs are a type of stem cell that can be removed from bone marrow samples and grown into many
      different cell types that can be used to treat cancer. The MSCs used in this study were
      collected from healthy male donors and are stored in a laboratory at MD Anderson. The use of
      male cells will help us to detect the cells that are infused versus your own female cells.

      The MSCs have been genetically changed in a laboratory at MD Anderson to add proteins called
      interferons. The MSCs will have genetic material introduced to them by a molecule called a
      plasmid that will help produce interferon beta. Interferons (IFNs) are proteins that may
      interfere with the growth of tumors. The MSCs will be grown in the laboratory and tested
      before they are given to you.

      MSC-INFb Dose Levels:

      If you are found eligible to take part in this study, you will be assigned to a dose level of
      MSC-INFb based on when you join this study. Up to 4 dose levels of MSC-INFb will be tested.
      Up to 3 participants will be enrolled at each dose level. The first group of participants
      will receive the lowest dose level. Each new group will receive a higher dose than the group
      before it, if no intolerable side effects were seen. This will continue until the highest
      tolerable dose of MSC-INFb is found.

      Your dose level may be lowered if you are not tolerating the MSC-INFb infusions. Your study
      doctor will discuss this with you.

      MSC-INFb Administration:

      About 1-2 weeks before your first MSC-INFb infusion, you will have an intraperitoneal (IP)
      catheter placed in your abdomen. A catheter is a sterile flexible tube that will be placed
      into your abdomen while you are under local anesthesia. Your doctor will explain this
      procedure to you in more detail, and you will receive a Patient Information Sheet that
      includes the definition of intraperitoneal therapy and information about the placement of the
      catheter and care of the catheter during the study. You will also be provided with a specific
      separate informed consent for the IP catheter placement by Interventional Radiology staff at
      MD Anderson.

      One time a week for up to 4 weeks (up to 4 times total), you will receive the MSC-INFb
      infusions through the IP catheter. The length of time for the infusion will depend on the
      size of the tumor.

      You will remain in the clinic for about 30 minutes for observation after each MSC-INFb
      infusion.

      Study Tests:

      About 1 week before your first MSC-INFb infusion:

        -  You will have a physical exam, including measurement of your weight and vital signs
           (blood pressure, heart rate, temperature, and breathing rate).

        -  Your medical history will be recorded.

        -  Blood (about 4 tablespoons each time) will be drawn for routine tests, to check your
           kidney and liver function, to check the status of the disease, and for INFb testing for
           comparison purposes. Blood tests may be repeated more frequently during the study if
           your doctor thinks it is needed.

        -  You will complete a symptom questionnaire. It should take about 10-15 minutes to
           complete.

      About 1-2 weeks before your first MSC-INFb infusion, during the same procedure as the IP
      catheter placement, you will have a tumor biopsy to check the status of the disease. To
      collect a tumor biopsy, the affected area is numbed with anesthetic and a small amount of
      tissue is withdrawn with a large needle. A day or two before your tumor biopsy, blood (about
      1 teaspoon) will be drawn to test clotting factors in your blood.

      Once a week for 4 weeks, before each MSC-INFb infusion:

        -  You will have a physical exam, including measurement of your weight and vital signs.

        -  Blood (about 4 tablespoons each time) will be drawn for routine tests, to check your
           kidney and liver function, to check the status of the disease and response to the
           infusion. °Blood tests may be repeated more frequently during the study if your doctor
           thinks it is needed.

        -  If you can become pregnant, you will have a blood or urine pregnancy test. If blood, it
           will be included in the routine blood draw listed above.

        -  Before the 1st, 2nd, and 3rd MSC-INFb infusion, you will complete a symptom
           questionnaire. It should take about 10-15 minutes each time to complete.

        -  Before each MSC-INFb infusion, up to 2 teaspoons of peritoneal fluid (if present) will
           be drawn through the catheter and stored in a laboratory at MD Anderson for future
           research related to this study.

      Before your peritoneal fluid can be used for research, the researchers must get approval from
      the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee of doctors,
      researchers, and community members. The IRB is responsible for protecting study participants
      and making sure all research is safe and ethical.

      Your samples will be given a code number. No identifying information will be directly linked
      to your samples. Only the researcher in charge of the bank will have access to the code
      numbers and be able to link the samples to you. This is to allow medical data related to the
      samples to be updated as needed.

      About 22-26 days after your last MSC-INFb infusion:

        -  Blood (about 1 teaspoon) will be drawn to test clotting factors in your blood.

        -  You will have a tumor biopsy and the IP catheter will be removed. The tumor biopsy will
           be tested to determine if the MSC-INFb infusions had any effect on the tumor.

        -  You will have CT scans of the chest, abdomen, and pelvis to check the status of the
           disease. This may be repeated every 2 months for up to 12 months starting about 22-26
           days after the last MSC-INFb infusion, if you doctor thinks it is needed.

      Follow-Up Visits:

      About 1 week after the last MSC-INFb infusion:

        -  You will have a physical exam, including measurement of your weight and vital signs.

        -  Blood (about 4 tablespoons) will be drawn about 1 week after the last MSC-INFb infusion
           for routine tests, to check your kidney and liver function, and to check the status of
           the disease and the response to the infusion. If your doctor thinks it is needed, blood
           (about 2 tablespoons each time) will be drawn at 44 days after the last MSC-INFb
           infusion and then once a month for 2 months to check the response to the infusions.

        -  You will complete a symptom questionnaire. It should take about 10-15 minutes to
           complete.

      Length of Study:

      You will be taken off study if the disease gets worse, if intolerable side effects occur, or
      your study doctor thinks it is in your best interest.

      Long-Term Follow-Up:

      For safety reasons, the U.S. Food and Drug Administration (FDA) requires that patients who
      receive infusions of stem cells treated with a gene transfer procedure must be followed have
      long-term follow-up for at least up to 15 years after receiving the gene transfer.

      Once a year for Years 1-5 after the last MSC-INFb infusion:

        -  Blood (about 2-4 tablespoons each time) will be drawn for routine tests.

        -  You will have a physical exam, including measurement of your vital signs.

        -  You will complete a questionnaire that asks about your medical history (your general
           health, the status of any medical conditions, and any illnesses or hospitalizations that
           may have occurred). It should take about 15-30 minutes to complete.

        -  You will be asked if there have been any changes in your contact information.

        -  If necessary to check the status of the disease, you will have computed tomography (CT)
           scans and/or additional routine blood tests (about 1-2 tablespoons).

      Once a year during Years 6-15 after the last MSC-INFb infusion, the research staff will
      contact you. Either over the phone, by email, or mail, you will fill out a questionnaire that
      asks about your medical history (your general health, the status of any medical conditions,
      and any illnesses or hospitalizations that may have occurred). The phone calls and
      questionnaires should take about 15-30 minutes each time.
    

Intervention name(s): MSC-INFβ; Questionnaires
Intervention type(s): Genetic; Behavioral
Intervention description(s): MSC-INFβ administered on an outpatient basis via intraperitoneal (IP) infusion.
Starting dose: 10^5 MSC/kg once a week for 4 treatments.; Symptom questionnaire completed once a week for 4 weeks.
Other intervention name(s): Mesenchymal stem cells with interferon beta; Surveys
Intervention MeSH terms: Interferons; Interferon-beta
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian cancer; Epithelial ovarian cancer; Mesenchymal Stem Cells Secreting Interferon Beta; MSC-INFb; Questionnaires; Surveys