[SysTaMatIcS]

What Will Happen to Patients in the Study?

Medical Tests

The following tests must be done to make sure that you are eligible for this study. Some of these tests are part of the study and generally would not be part of your routine clinical care. Depending on when you last had them, you may need to repeat some of these tests:

• Blood tests
• CT/MRI scan of the chest, abdomen, and pelvis
• CT/MRI of brain
• HIV Test
• Pregnancy test if you are of childbearing potential

After screening tests are obtained, it is possible that based on the results, you might not be eligible to be treated on this protocol.
Many of these tests will be repeated during the study. If you participate in this study, some of these tests may be done more frequently than if you were not taking part in this research study.
Some of your blood will be sent to a research laboratory to evaluate how well your body has accepted the blood cells from your donor. The blood will be collected prior to beginning treatment on this study, immediately before and after the first white cell infusion on day+1, before the second infusion on day+2, and day+7 days or immediate after the last infusion of white cells. In addition, there will be blood draws to check how well white cells in your blood kill cancer cells in the laboratory following white cell transfusions. During the treatment period, you will have daily blood counts checked.
You will be asked to consider letting the doctors take a biopsy or fine needle aspiration of your cancer shortly after treatment begins, if it is easily accessible, such as tumors under the skin or in the superficial lymph nodes. If you agree, the biopsy will take place during the first week of your treatment. The researchers in the study will look at the tumor tissue under the microscope to see whether the white cells are surrounding the tumor. You do not have to agree to have the biopsy to participate in this treatment program.

Treatment

Treatment on this research study is an experimental and unproven way to treat cancer. This treatment uses healthy donors’ white blood cells to fight your disease. If you agree to participate, you will receive daily infusions of white cells through a line inserted into a vein in your arms, or through the central venous line if available. The number of infusions you will receive will depend on the number of white cells obtained from the donors. You will receive white cell infusion until an adequate number of cells have been infused. We predict that several donors will be required to achieve that cell dose.
The white cells transfused are also called granulocytes. They are collected from healthy blood donors at the American Red Cross using standard granulocyte collection procedures. They donors will be selected and screened by the current standards of blood donations according to the American Association of Blood Banking (AABB) and Food and Drug Administration (FDA). These donors are volunteers, and will be screened by the study team for blood donation eligibility. In addition, these donors will be tested to have reasonable cancer killing activity (CKA) in their blood as described above, compatible blood types (they will be compatible for ABO and Rh blood type with you), to pass a panel of infectious disease blood tests and to have different tissue types or the so-called human leukocyte antigens (HLA) which will lessen the chance of a serious side effect called transfusion-associated graft versus host disease (TAGVHD).
Granulocyte transfusions have been used in clinical practice for more than 30 years to treat patients who have life-threatening infections and have very low white cell count following chemotherapy. In that setting, granulocyte infusions are given to help the patients fight infections. In this clinical trial granulocyte infusions are given to hopefully help you fight cancer.
We estimate that several infusions will be needed to achieve the target cell dose. Transfusions of white cells will be administered daily. It is possible that treatment interruptions might occur, and treatment delay up to 7 days is allowed.
Donors will be asked to take dexamethasone (a steroid pill) and/or filgrastim (Neupogen) the day the before collection of cells. These two medications are widely used in clinical practice to increase the yield of white cells during collection.
White cell infusions might be administered before infectious disease marker results obtained on the day of collections from the given donor are available from the Red Cross. All donors registered to this study will be tested and screened for infectious disease markers at the time of donor registration and they will be re-tested in American Red Cross on the day of donation. Granulocytes are generally available for transfusion within approximately 24 hours after collection; at that time the infectious disease markers obtained on the day of collection are generally not yet available. Donors will have had recent (within 30 day) infectious disease markers to exclude known blood-borne diseases, and will have passed the universal donor questionnaire on the day of donation. This practice is consistent with current clinical practice, given the short life span of granulocytes. Results of these tests will become available and will be shared with you.
Your doctor may give you medications to prevent transfusion reaction, and/or to treat the reaction should it occur. Such medications may include acetaminophen (Tylenol), diphenhydramine (Benadryl) and/or hydrocortisone (a steroid).
You will be monitored closely daily with blood tests during treatment, and monthly after treatment. Your cancer will be assessed three months after the treatment is finished. You might receive other treatments for your cancer if it is getting worse during that time. If your cancer is not getting worse, you will be asked not to take other treatments for your cancer during those three months.

How Long Will I Be in the Study?

We think you will be in the study for approximately 3-5 months. The researcher or your regular doctor may decide to take you off this study if:

• The treatment does not work in your cancer.
• Your health gets worse.
• Your cancer begins to grow.

You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the researcher and your regular doctor first.