Clinical trial NCT00412425
Conditions: Melanoma
Keywords: Melanoma Nausea Vomiting Palonosetron Cisplatin Vinblastine Loss of Appetite Weight loss
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-11-01; Completion date: 2009-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: 2 Days Palonosetron 0.25 mg intravenous (IV) arm 2: 3 Days Palonosetron 0.25 mg IV
Interventions: intervention 1: Palonosetron
Intervention descriptions: intervention 1: 0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.

Protocol documents: