A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma

Exclusion Criteria

• •1. Women who are pregnant or lactating and women of childbearing potential and fertile men not agreeing to a medically effective method of contraception. Women of childbearing potential will be informed as to the potential risk of procreation while participating in this study and will be advised that they must use effective contraception (e.g. oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) during the treatment period and for a period of 3 months following the completion of dosing.
• •2. Patients with significant cardiovascular disease as defined by The New York Heart Association Classification (Class III or higher)
• •3. Patients with symptomatic or known brain metastases unless patient has undergone radiotherapy (or treatment with gamma knife) or resection of an isolated lesion and maintenance steroids are not required
• •4. Patients with a history of another malignancy within the last 2 years with the exception of:
• •* Treated, non-melanoma skin cancers
• •* Carcinoma in situ of the breast or cervix
• •* History of T1a or b carcinoma of the prostate detected incidentally and comprising \<5% of resected tissue, with PSA within normal limits since resection
• •5. Patients with any uncontrolled infection or other intercurrent illness
• •6. Patients with any history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of an underlying disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
• •7. Patients with known HIV infection
• •8. Patients with inadequate recovery from any prior surgical procedure
• •9. Patients with psychiatric disorders or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
• •10. Patients with any prior monoclonal antibody therapy for melanoma
• •11. Patients previously treated with any other immunotherapy, vaccine, or biological response modifier therapy for melanoma, either during or within four weeks prior to study entry
• •12. Patients with systemic hormonal therapy, either during or within four weeks prior to first dose of KW-2871, unless for appetite stimulation
• •13. Patients requiring maintenance systemic steroid therapy for any condition
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