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Human / Clinical Studies

    The anticancer potential of Newcastle disease virus (NDV) has been investigated in clinical studies in the United States, Canada, China, Germany, and Hungary. These studies have evaluated the use of oncolysates,[1,2,3,4,5,6,7,8,9,10,11,12,13] Reviewed in [14]whole cell vaccines,[15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33] Reviewed in [14,34,35,36,37] and infection of patients with a lytic strain of the virus.[38,39,40,41,42,43,44,45,46,47,48] Reviewed in [14,49,50,51,52] Findings from most of the studies, almost all of which were phase I or phase II clinical trials, have been reported in English-language biomedical journals. Overall, the results of these studies must be considered preliminary. Most studies enrolled only small numbers of patients, and historical control subjects, rather than actual control groups, which were often used for outcome comparisons. In addition, the evaluation of many studies is made difficult by poor descriptions of study design and the incomplete reporting of clinical data.

    Immunotherapy With Oncolysates

    The following information is summarized in a table located at the end of this section.

    The use of NDV oncolysates in patients with metastatic melanoma was evaluated in four clinical studies in the United States.[1,2,4,6,9,10,11] Reviewed in [14] Three of these studies—a phase I clinical trial [9,10] and two phase II clinical trials [1,2,4,11]—were conducted by the same group of investigators. In all four studies, NDV strain 73-T was used to prepare oncolysate vaccines.

    In the phase I study,[9,10] 13 patients who had advanced disease and who had not responded to conventional therapy (surgery alone or surgery plus chemotherapy and/or radiation therapy) were treated subcutaneously once a week or once every other week with injections of NDV oncolysates prepared from either their own tumor cells (i.e., autologous vaccines) or cultured melanoma cell lines (i.e., allogeneic vaccines). Several patients received additional conventional therapy while undergoing NDV treatment. Blood samples collected during the study showed increases in T cell numbers and the cytotoxic activity of lymphocytes in most patients (the latter was measured against melanoma cells in vitro).[9] One patient showed a complete response.[10] This patient, who was alive and apparently cancer-free at the end of the study period (a survival of more than 112 weeks), received six courses of chemotherapy while undergoing oncolysate treatment and had the least advanced disease of the patients studied. Minor responses in some skin and lymph node metastases were noted in several other patients, but no responses in visceral metastases were detected.

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