Ipilimumab + Temozolomide in Metastatic Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.

      Study Drugs:

      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.

      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 weeks.

      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.

      Study Tests:

      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
           kidney function.

        -  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.

      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
      Visit.

      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.

      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 MD Anderson.
    

Intervention name(s): Ipilimumab; Temozolomide
Intervention type(s): Drug; Drug
Intervention description(s): Induction Phase: 10 mg/kg by vein (IV) over approximately 90 minutes on Day 1 only repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose repeated every 12 weeks.; Induction Phase, 200 mg/m^2 by mouth (PO) on Days 1 to 4, repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose delivered on Days 1 to 5, repeated every 4 weeks.
Other intervention name(s): BMS-734016; MDX010; Temodar
Intervention MeSH terms: Temozolomide; Ipilimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced; Inoperable; Melanoma; Ipilimumab; MDX010; BMS-734016; Temozolomide; Temodar; TMZ; skin; mucosal