A Phase I Open-label Study of the Safety and Immunogenicity of Escalating Doses of Lipovaxin-MM, a Novel Melanoma Immunotherapeutic, in Patients With Metastatic Melanoma

ipotek Pty Ltd0 个研究点目标入组 24 人开始时间: 2010年2月12日最近更新: 2020年1月13日

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•Patients with incurable stage 4 (IV) malignant melanoma for which no standard or curative therapy exists OR patients with locoregionally recurrent melanoma (including local metastases, in transit metastases and satellitosis) where surgery is not the best therapeutic option . Must be able and willing to provide written informed consent. Eastern Cooperative Oncology Group Performance Status of 0 or 1. Life expectancy of at least 12 weeks. Female subjects must be of non-child-bearing potential or using appropriate contraception. Positive test for cell mediated immunity.

•Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry and stable without steroid treatment for at least 4 weeks.
•Previous immunotherapy (except interleukin-2 (IL-2)- or interferon-based therapy) for melanoma.
•Inadequate bone marrow reserve.
•Serum bilirubin at least 1.2 times the upper limit of normal.
•In the absence of metastases, liver transaminase levels greater than 1.5 times the upper limit of normal.
•If metastases are evident, liver transaminase levels 2.5 times the upper limit of normal will be acceptable.
•Inadequate renal function.
•Evidence of severe or uncontrolled systemic diseases.
•Unresolved toxicity at least Common Toxicity Criteria (CTC) Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
•Participation in a trial of an investigational agent within the prior 30 days.
•Human immunodeficiency virus (HIV) infection.
•Immunosuppressive therapy including corticosteroids within 4 weeks of screening.
•Pregnant or breast-feeding females.

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ipotek Pty Ltd