Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to learn if the combination of ipilimumab and
      ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug
      combination will also be studied.

      Ipilimumab is designed to increase the immune system's ability to fight cancer.

      Abraxane is designed to stop cancer cells from making new DNA (the genetic material of
      cells). This may stop the cancer cells from dividing into new cells.
    

Detailed description: 
      Study Drug Administration:

      If you are found to be eligible to take part in this study, you will receive ABI-007 by vein
      over about 30 minutes on Days 1, 8, and 15 of each 28-day cycle. During the first 3 months
      that you receive abraxane, you will also receive ipilimumab. You will receive ipilimumab by
      vein over about 90 minutes. You will receive it 4 times, each time about 3 weeks apart.

      You will be given standard drugs to help decrease the risk of side effects. You may ask the
      study staff for information about how the drugs are given and their risks.

      Study Tests:

      Every week, blood (about 1 teaspoon) will be drawn for routine tests.

      Before each cycle of abraxane:

        -  Your performance status will be recorded.

        -  You will have a physical exam, including measurement of your weight and vital signs.

        -  Blood (about 1 teaspoon) will be drawn for routine tests.

        -  Blood (about 1 teaspoon) will be drawn for tests of the immune system (first 3 cycles
           only).

        -  You will be asked about any other drugs you may be taking and about any side effects you
           may be having.

        -  If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
           pregnancy test.

      Every 8 weeks (+/- 7 days), you will have a chest x-ray and CT scans or MRI scans performed
      to check the status of the disease.

      Length of Study:

      You may receive ipilimumab for up to 3 months. You may continue taking abraxane 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 measurement of your vital signs and weight.

        -  You will be asked about any other drugs you may be taking and any side effects you may
           be having.

        -  Blood (about 2 tablespoons) will be drawn for routine tests.

        -  If the study doctor thinks it is in your best interest, you will have a CT scan or MRI
           scan to check for side effects.

      Every 2 months for 6 months, then every 3 months for up to 2 years, you will also be
      contacted by telephone or during a routine clinic visit to see how you are doing. If you are
      called, each call should last about 5 minutes.

      This is an investigational study. Ipilimumab is FDA approved and commercially available for
      the treatment of metastatic melanoma. abraxane is FDA approved and commercially available for
      the treatment of metastatic breast cancer. It is investigational to use abraxane, either
      alone or in combination with ipilimumab, for the treatment of metastatic melanoma.

      Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.
    

Intervention name(s): ABI-007; Ipilimumab; Phone Call
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.; 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.; Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
Other intervention name(s): Nab-paclitaxel; Paclitaxel; Abraxane; Yervoy; BMS-734016; MDX010
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Ipilimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; Metastatic Melanoma; Advanced stage IV melanoma; Unresectable stage III mucosal melanoma; Cutaneous melanoma; Progression-free survival; (PFS); ABI-007; Nab-paclitaxel; Paclitaxel; Abraxane; Ipilimumab; Yervoy; BMS-734016; MDX010