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Human / Clinical Studies

    Table 2. Studies of NDV Oncolysates in Which Therapeutic Benefit Was Assesseda,b

    Reference Citation(s)Type of StudyType of CancerNo. of Patients: Enrolled; Treated; ControlcStrongest Benefit ReporteddConcurrent TherapyeLevel of Evidence Scoref
    No. = number.
    a See text and theNCI Dictionary of Cancer Termsfor additional information and definition of terms.
    b Oncolysates are prepared from virus-infected cancer cells; they consist primarily of cellmembranefragments and contain virusproteinsand cancer cell proteins.
    c Number of patients treated plus number of patients control may not equal number of patients enrolled; number of patients enrolled = number of patients initially recruited/considered by the researchers who conducted a study; number of patients treated = number of enrolled patients who were given the treatment being studiedAND for whom results were reported; historical control subjects are not included in number of patients enrolled.
    d The strongest evidence reported that the treatment under study has anticancer activity or otherwise improves the well-being of cancer patients.
    e Chemotherapy, radiation therapy,hormonal therapy, or cytokine therapy given/allowed at the same time as oncolysate treatment.
    f For information about levels of evidence analysis and an explanation of the level of evidence scores, seeLevels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.
    [1,2,4,11]Phase II trialAdvanced melanoma32; 32; Historical controlsImproved overall survivalNo3iiA
    [1,2,11]Phase II trialAdvanced melanoma51; 51; Historical controlsImproved overall survivalNo3iiA
    [6]Phase II trialAdvanced melanoma24; 24; Historical controlsNoneNo3iiDi
    [5,7]Phase II trialMetastatic breast or ovarian22; 22; NoneComplete/partial tumor response, 9 patientsYes3iiDiii
    [8,12]Phase II trialAdvanced renal cell208; 203; Historical controlsImproved disease-free survivalYes3iiiDi
    [9,10]Phase I trialAdvanced melanoma13; 13; NoneComplete tumor response, 1 patientYes3iiiDii

    Immunotherapy With Whole Cell Vaccines

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

    Most clinical studies of NDV-infected, whole cell vaccines that have been reported in scientific literature were conducted in Germany.[15,16,17,18,19,20,21,22,23,24,25,26,27,31,32] However, the largest reported trial was performed in China.[33] Reviewed in [14,34,35,36] Most of these studies involved patients with colorectal cancer,[15,16,19,20,22,33] breast cancer,[17,18,25] ovarian cancer,[17,18,23] renal cell cancer,[21,26] or malignant glioma.[31] The nonlytic strain NDV Ulster was used to prepare autologous tumor cell vaccines in all of the studies.

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