PHASE II TRIAL OF HU1418-IL2 (EMD 273063) IN SUBJECTS WITH ADVANCED MELANOMA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is testing a genetically engineered fusion protein EMD 273063 for the treatment of patients with advanced melanoma. We expect to enter 14-30 patients into this trial. The purpose of this trial is to evaluate whether EMD 273063 has antitumor activity in patients with advanced melanoma. EMD 273063 is an immunocytokine. This compound has been created by linking two separate anticancer molecules together and is experimental. The components of EMD 273063 are the humanized 14.18 monoclonal antibody (hu14.18 antibody) and interleukin-2 (IL2). The IL2 molecule is a standard form of treatment for some cancers, including melanoma. IL2 activates immune cells. Studies have shown that while IL2 treatment may shrink melanomas in approximately 16% of individuals with advanced melanoma, the tumors generally grow back. The hu14.18 molecule is a humanized monoclonal antibody that binds to the GD2 molecules (binding sites) found on melanoma cells. The 14.18 antibody binds preferentially to tumor cells (has a greater chance of binding to cancer cells than to normal tissues), but when used alone, doesn't activate the immune system to destroy tumor very well. In theory, the hu14.18 portion of EMD 273063 will lead the IL2 directly to the tumor cells, where IL2 can activate immune cells to kill the tumor cells. Though this type of reaction has been observed in laboratory animals, it is not known if this molecule will have the same antitumor activity in melanoma patients. This study will determine the immune effects and antitumor effects of this treatment for melanoma patients.