Newcastle Disease Virus (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI] - Human / Clinical Studies
Table 2. Studies of NDV Oncolysates in Which Therapeutic Benefit Was Assesseda,b
|Reference Citation(s)||Type of Study||Type of Cancer||No. of Patients: Enrolled; Treated; Controlc||Strongest Benefit Reportedd||Concurrent Therapye||Level 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 trial||Advanced melanoma||32; 32; Historical controls||Improved overall survival||No||3iiA|
|[1,2,11]||Phase II trial||Advanced melanoma||51; 51; Historical controls||Improved overall survival||No||3iiA|
|||Phase II trial||Advanced melanoma||24; 24; Historical controls||None||No||3iiDi|
|[5,7]||Phase II trial||Metastatic breast or ovarian||22; 22; None||Complete/partial tumor response, 9 patients||Yes||3iiDiii|
|[8,12]||Phase II trial||Advanced renal cell||208; 203; Historical controls||Improved disease-free survival||Yes||3iiiDi|
|[9,10]||Phase I trial||Advanced melanoma||13; 13; None||Complete tumor response, 1 patient||Yes||3iiiDii|
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. 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. The nonlytic strain NDV Ulster was used to prepare autologous tumor cell vaccines in all of the studies.
Data from a 2004 pilot clinical trial of an NDV-modified autologous tumor vaccine in 20 patients with stage III or IV head and neck squamous cell carcinomas suggest that the vaccine strategy can stimulate human antitumor immune responses in a manner similar to those found in animal models and may significantly prolong 5-year survival rates in this patient population. The study demonstrated the feasibility and safety of the vaccine regimen, and no major side effects were observed in any of the patients.