Phase II Study of Ipilimumab Plus Temozolomide in Patients With Metastatic Melanoma
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
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.
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 an intravenous (IV) catheter
placed into a large vein for the Ipilimumab.
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
You may take the Temozolomide dose within 48 hours of receiving the Ipilimumab dose on Day 1
of both the Induction and the Maintenance Phase.
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 and tests of your liver and
- You will be asked about any medication you are taking and any side effects you are
- Women who are able to become pregnant will have a blood (about 1 teaspoon) or urine
- 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.
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 (+/- 7 days), 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
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
- 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.
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
Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6-Month Progression-Free Survival (PFS) Rate
Sapna P. Patel, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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