RECOMBINANT INTERLEUKIN 12 IN PATIENTS W/ STAGE IA, IB OF IIA MYCOSIS

University Of Pennsylvania, Philadelphia PA

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Abstract

Mycosis fungoides (MF) is an idolent lymphoproliferative disorder that presents with patchy skin lesions infiltrated with a clonal population of malignant T-cells often unrecognized as a herald of malignancy. Once the diagnosis is made, initial treatments are topical agents or ultraviolet based phototherapies. As is the case with most newly diagnosed lymphoproliferative disorders, the disease is originally responsive to a variety of agents. However, very few early stage patients are "cured" of their disease and eventually, most patients develop more advanced disease which is refractory to the standard treatments. The treatment of MF patients with rhIL-12 may directly inhibit the malignant T clone by suppressing the autocrine growth factor as well as stimulate a tumor specific cytoxic response. This trial will be an open label study to evaluate the efficacy and safety of subcutaneous rhIL-12 during the 6 months of treatment. A sufficient number of patients with Mycosis Fungoides Cooperative Group (MFCG) Stage Ia through IIa (see Attachment 2) will be assigned to ensure 36 valuable patients for response analysis. An interim analysis will be performed after the initial 18 patients have completed treatment and 18 additional patients may be enrolled. All patients receiving rhIL-12 will be included in the analysis of safety.