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The goal of this clinical research study is to learn if combining Ipilimumab and Temozolomide can help to control metastatic melanoma. The safety of this drug combination will be studied. Researchers would also like to study how this therapy affects the levels of certain chemicals in the blood that are related to your immune system.
The ability to control melanoma depends on how well your immune system recognizes and then attacks cancer cells. Researchers want to use Ipilimumab to try to trigger your immune system response, while Temozolomide is designed to damage the cancer cells themselves.
Ipilimumab is designed to block the activity of cells that lower the immune system's ability to fight cancer. Blocking these cells may help the body's immune system fight the cancer cells better.
Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). If they cannot make DNA, then they cannot divide into new cancer cells.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed within 14 days before you begin receiving the study drugs:
- You will have your complete medical history recorded.
- You will also be asked about any symptoms you are experiencing and any medication you are taking.
- You will have a complete physical exam, including measurement of your height, weight, and vital signs (temperature, heart rate, breathing rate, and blood pressure).
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
- Blood (about 2 teaspoons) will be collected for routine blood tests.
- You will have an electrocardiogram (ECG--a test to measure the electrical activity of the heart).
- You will have several scans to check the status of the disease, including a chest X-ray, a magnetic resonance imaging (MRI) scan of the brain, and a computed tomography (CT) scan of the chest, abdomen, and pelvis.
- If you have breathing problems, you will have a breathing test to measure how much air your lungs can hold and how much air you can exhale.
- Women who are able to become pregnant must have a negative blood (about 1 teaspoon) or urine pregnancy test within 72 hours (3 days) before the start of ipilimumab therapy.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin to receive treatment with ipilimumab plus temozolomide. You will have a central venous catheter (CVC) placed before you begin receiving treatment. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
There are 2 phases of study drug treatment: Induction and Maintenance.
During the Induction Phase, you will receive ipilimumab by vein over 90 minutes on Day 1 of each 3-week Induction "course." You will take temozolomide by mouth in tablet form on Days 1-4 of each course. You will receive up to 4 courses of Induction therapy.
During the Maintenance Phase, you will receive ipilimumab by vein over 90 minutes on Day 1 every 12 weeks. You will also take temozolomide by mouth for 5 days in a row, every 4 weeks.
You will see your doctor before each new course (every 3 weeks) during the Induction Phase, and once every 4 weeks during the Maintenance Phase. All treatments will be given in the outpatient clinic. You will be given anti-nausea medication to decrease the risk of nausea and vomiting, as needed.
Before Each Course:
(Every 3 weeks during Induction, and every 4 weeks during Maintenance)
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will be asked about any medication you are taking and any side effects you are experiencing.
- Women who are able to become pregnant will have a blood (about 1 teaspoon) or urine pregnancy test.
- Your performance status will be recorded.
- Your vital signs will be measured on Day 1.
Every week, blood (about 1 teaspoon) will be drawn for routine tests and tests of your liver and kidney function.
At the end of each course, any tumor that can be felt with the hands will be measured during physical exam to see if it is shrinking.
Every 2 courses, you will have a chest x-ray and CT or MRI scans performed to check the status of the disease.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
If you stop receiving the study drugs for any reason, you will have an End-of-Treatment Visit.
Within 14 days after you stop study treatment, you will come into the clinic for the End-of-Treatment Visit. At this visit, the following tests will be performed:
- You will have a physical exam, including a measurement of your vital signs and weight.
- You will be asked about any other medications you are taking or any side effects you are experiencing.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- Your may have a CT or MRI scan performed to check for side effects.
Every 2 months for up to 3 years, you will also be contacted by telephone or during a clinic visit to see how you are doing.
Additional Study Instructions:
- You must follow all instructions and directions you are given while on study.
- You must tell your doctor about any medication, over-the-counter products, herbal remedies, or alternative therapies that you use while you are on this study.
- You should not have any immunizations (vaccinations) without telling your doctor first.
- You should not donate blood while on study or for 70 days after your last dose of the study drugs.
- You must tell your doctor about any medical treatments that you will have during the study (such as elective surgery).
This is an investigational study. At this time, temozolomide is FDA approved and commercially available for the treatment of primary brain cancer. However, the use of temozolomide in treating metastatic melanoma is considered investigational. At this time, ipilimumab is being used in research only. The use of these drugs together is also considered investigational.
Up to 64 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:13:52-0400
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