Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting
Condition: Melanoma
MeSH terms: Melanoma; Nausea; Vomiting
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary Objectives:

        -  Safety of palonosetron administered for control of nausea and vomiting in patients with
           metastatic melanoma receiving biochemotherapy.

        -  To determine the patterns and severity of nausea and vomiting in two groups of patients
           with metastatic melanoma receiving biochemotherapy with palonosetron premedication using
           two schedules of palonosetron administration.
    

Detailed description: 
      Palonosetron is designed to work by blocking the substance serotonin from binding to the
      brain and gastrointestinal tract, which may help to decrease nausea and vomiting.

      Participants in this study will be receiving biochemotherapy treatment as part of their
      routine care. This treatment will include 3 chemotherapy drugs (cisplatin, vinblastine, and
      DTIC) and 2 drugs that stimulate the immune system (interferon and interleukin-2 (IL-2)).
      Biochemotherapy often causes nausea, vomiting, loss of appetite, and weight loss.
      Palonosetron will be given on this study to try to treat the side effects of biochemotherapy.

      If you agree to take part in this study, you will be randomly assigned (as in the toss of a
      coin) to one of 2 treatment groups. You have an equal chance of being assigned to either
      group.

      Participants in Group 1 will receive palonosetron by vein over a few minutes starting 30
      minutes before receiving chemotherapy on Days 1 and 4 of therapy. Participants in Group 2
      will receive palonosetron by vein over a few minutes on Days 1, 3, and 5.

      All participants on this study will also receive Ativan by vein every 8 hours for 5 days.
      Ativan is given for additional control of nausea and it will also help to sedate you. In
      addition to palonosetron, you may be given standard anti-nausea medications such as lorazepam
      or compazine if you experience intolerable nausea and vomiting while on study.

      You will also be asked to fill out a Functional Living Index-Emesis (FLIE) questionnaire
      every day for 7 days in a row. The questionnaire will ask about any nausea and/or vomiting
      you are experiencing and the effect of the therapy on your quality of life. You will stay in
      the hospital for at least 7 days while you receive treatment.

      After the first course of palonosetron given with biochemotherapy, your doctor will decide if
      you will receive additional courses of palonosetron or if you will be given another
      anti-nausea drug.

      If your doctor does decide to have you continue on palonosetron, it will be given off study.
      Your participation in this study will be over after 1 course.

      This is an investigational study. Palonosetron has been approved by FDA for control of nausea
      and vomiting caused by chemotherapy. However, it has not been adequately evaluated for safety
      and effectiveness in patients receiving high dose interleukin-2 alone or in combination with
      chemotherapy. About 30 patients will take part in this study. All patients will enrolled at
      M. D. Anderson.
    

Intervention name(s): Palonosetron
Intervention type(s): Drug
Intervention description(s): 0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.
Intervention MeSH terms: Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; Nausea; Vomiting; Palonosetron; Cisplatin; Vinblastine; Loss of Appetite; Weight loss