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 continued...
The phase II trial that involved patients with locally advanced colorectal carcinoma (i.e., large tumors and no regional lymph node metastasis or tumors of any size and regional lymph nodes that were positive for cancer) recruited 57 individuals. Among these 57 patients, 48 were treated with NDV-infected, whole cell vaccines, and 9 were treated with vaccines composed of autologous tumor cells and the bacterium Bacillus Calmette Guerin (BCG), which also has been used as an immune system stimulator. Patients recruited for this trial were treated first with surgery and then were given a choice between participating in the trial or receiving chemotherapy. The individuals who chose to participate in the trial were injected intradermally with the appropriate autologous tumor cell vaccines every other week for a total of 6 weeks (i.e., 3 vaccinations per patient) beginning 6 to 8 weeks after surgery. The follow-up period ranged from 6 months to 43 months (median of 22 months), and disease-free survival and overall survival were estimated for the vaccinated patients and for 661 historical control subjects who were treated with surgery alone. Two years after surgery, overall survival for the patients who were treated with NDV-infected, autologous whole cell vaccines was 98%, compared with 67% overall survival for the patients who were treated with BCG tumor cell vaccines and 74% overall survival for the historical control subjects. The differences in survival between the NDV/tumor-cell–vaccinated group and the other two groups were statistically significant. Disease-free survival 2 years after surgery for the NDV/tumor-cell–treated patients was 72%. The researchers who conducted this trial also reported that overall survival for the NDV/tumor-cell–treated group was comparable to that of the group of patients (n = 15) who chose to be treated with chemotherapy rather than immunotherapy.
Two additional phase II studies investigated the use of NDV-infected, autologous tumor cell vaccines in patients who had either ovarian cancer or renal cell cancer.[21,23] The ovarian cancer trial enrolled 82 patients, but only 39 were evaluable for response. The published report of this trial, however, described clinical findings for just 24 evaluable patients who had stage III disease; results for the remaining evaluable patients (5 with stage I disease, 5 with stage II disease, and 5 with stage IV disease) were not presented. The patients in this trial were treated with surgery and six courses of chemotherapy in addition to three courses of intradermally administered immunotherapy, but details about the adjuvant treatments (e.g., what constituted a course of immunotherapy or what chemotherapy drugs were used in addition to cisplatin) were very limited. Among the 24 evaluable patients with reported clinical findings, 15 had a complete remission, 8 had a partial remission, and 1 had progressive disease. The median disease-free survival time for the patients who had a complete remission was 30 months. These results were described as very encouraging by the investigators who conducted the study, but the degree of benefit afforded by the immunotherapy in this uncontrolled study cannot be established. In common with other studies of NDV-infected tumor cell vaccines, histologic examination of individual vaccination sites revealed the presence of infiltrates consisting predominantly of helper T cells.