Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

Inclusion Criteria

• They have non-resectable stage III or IV metastatic melanoma with measurable disease and have agreed to be treated with biochemotherapy.
• They have Zubrod performance status of 0-1
• They have normal blood counts with a white blood count (WBC) count >/= 3,500/mm^3, ANC >/= 1,500/mm^3 and a platelet count >/= 100,000/mm^3 and have serum creatinine 11 mg), gastro-intestinal (GI) bleeding or evidence of brain metastasis.
• They have not been exposed to prior interferon, interleukin-2 or previous chemotherapy including regional perfusion. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
• They must have been off corticosteroids for at least 2 weeks.

Exclusion Criteria

• They are younger than 18 years or more than 65 years of age and those with an expected survival of less than 8 weeks or a Zubrod performance status of 2, 3 or 4.
• They have received previous treatment with any prior systemic chemotherapy for unresectable metastasis including and not limited to the following drugs: cisplatin, vinblastine, Dacarbazine (DTIC), interferon and interleukin-2
• They have active central nervous system involvement by melanoma either as brain metastasis, spinal cord compression, or meningeal carcinomatosis".
• They have significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricular function or serious cardiac arrhythmias requiring therapy.
• They have significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD).
• They have symptomatic effusions on account of pleural, pericardial or peritoneal metastasis of melanoma.
• They have history of a second malignant tumor (except for other skin cancers and in situ carcinoma of the cervix) within the past 5 years and uncertainty about the histologic nature of the metastatic lesions.
• They are on corticosteroids or any other type of immunosuppressive agent (e.g., methotrexate, chloroquine, azathioprine, cyclophosphamide).
• They are pregnant or breast feeding. Patients of childbearing potential must agree to use an effective method of contraception.
• They have known hypersensitivity to any of the study drugs or to other selective 5-HT3(subscript).
• They have ongoing emesis due to any organic etiology including but not limited to central nervous system or gastrointestinal metastasis.
• They have grade 2 or higher nausea due to administration of drugs including but not limited to narcotics.