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Project Title Phase Ib Trial of 2nd Generation Designer T Cells in Metastatic Breast Cancer

Researcher Richard Junghans, PhD, MD, Associate Professor of Medicine, Boston University School of Medicine, and Roger Williams Medical Center, Providence, Rhode Island

Study Summary The purpose of this Phase Ib clinical trial is to determine whether a high dose of designer T cells is better when given with or without interleukin 2 (IL2), a drug that is thought to stimulate the immune system. For this reason, some of the study participants will receive modified T cells alone, whereas others will receive modified T cells along with IL2. The researcher would like to enroll about 12 people in this study.

Phase I studies typically look at the safety and side effects of a new treatment. This is a Phase Ib study, so it is not only monitoring safety but also looking at whether the experimental treatment being studied is effective. In this case, effectiveness will be measured by how active the T cells become and how much the tumor shrinks.

Who Can Participate? You can join the Phase Ib Trial of 2nd Generation Designer T Cells in Metastatic Breast Cancer if you match ALL of these MAIN categories:

• You are 18 years of age or older
• You have Stage IV, metastatic breast cancer (breast cancer that has spread in your body)
• You have received at least two prior chemotherapies that failed OR at least one prior hormonal therapy and one prior chemotherapy that failed
• You are NOT currently pregnant
• You live near or are willing to travel (at your own expense) to the Roger Williams Medical Center in Providence, Rhode Island

Please note that these are only the MAIN eligibility criteria and the research team will need to review your medical records and ask additional questions to determine if you are eligible for the clinical trial. After you RSVP, the research staff will contact you to ask additional questions to be sure that this study is the right fit for you.

What Does Participation Involve? If you sign up for the Phase Ib Trial of 2nd Generation Designer T Cells in Metastatic Breast Cancer, you will be contacted by the research team to answer questions about your breast cancer diagnosis and treatment and medical history. You will also be asked to sign a medical release to permit the researchers to confirm your breast cancer diagnosis with your physician and to access relevant medical records.

If you appear to be eligible, and if you decide to join the study, you will mainly be followed as an outpatient in the Oncology Unit of the Roger Williams Medical Center in Providence, Rhode Island. However, you will have an inpatient admission to administer the modified T cells.

Study procedures:

• Physical examination, chest x-ray, urine test, EKG (basic heart test), a pulmonary function test to determine how well your lungs are working, and blood tests. If you are over 50 years of age or have a history of heart problems, you will be asked to have a cardiac stress test.

• Your study doctor will review your past medical history to determine if you are eligible to participate. You will also be scheduled for collection of your T cells. The exact number of visits to the Clinic to collect the T cells varies by individual. Your doctor will discuss this with you at length.

• You will be randomly assigned (like the flip of a coin) to one of two groups:
o Modified T cells alone
o Modified T cells with Interleukin-2 (IL2)

• Taking blood to collect your T cells: You will have a needle inserted into a vein in each arm. A machine will draw blood out of one arm, collect the white blood cells from the blood and then return the blood from which the white cells have been collected back to you through the other arm. This procedure takes from one to three hours. It is called leukopheresis.

• It will take about one to two months for your white blood cells to be modified. During this time you will not need to return to the Clinic. You will be contacted when your cells are ready. At that time you will make an appointment to be admitted to the hospital for an inpatient stay of approximately 24 hours. The modified T cells will be given through a vein in your arm or through your catheter over a 30 to 60 minute period. After the 24 hour admission period you will be discharged to your home as long as your doctor feels it is safe to do so. During the inpatient stay you will have a physical examination and blood tests.

• If you receive IL2, this will be given when you receive the modified cells. If you don’t already have a port, you will first need to have a minor surgical procedure to place a central venous catheter just under the skin on your chest wall. The IL2 is then given through this catheter using a pump (about the size of a portable CD player) that you will wear in a pouch on your waist. IL2 will be infused continuously for two weeks after the dose of modified T cells.

• Blood sampling: Approximately 10 tablespoons of blood will be taken from a vein in your arm before and after the infusion of modified cells. You will have additional blood tests over the next one to five days, and each time about 4 tablespoons of blood will be taken. You will then return to the Clinic weekly for three weeks for a physical examination and blood tests (4 tablespoons from a vein in your arm) will be taken again. One month after you receive the T cells you will have another physical examination, blood tests (4 tablespoons from a vein in your arm), and x-rays and/or scans of your tumor.

• Biopsies: you will have a biopsy of your tumor as an outpatient procedure at two different times after you receive the modified cells. This would happen on approximately the second and tenth day after you have received the modified cells.

Where? Roger Williams Medical Center, Providence, Rhode Island