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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 use of NDV-infected, whole cell vaccines in patients with either locally advanced or metastatic colorectal carcinoma was examined in one phase I clinical trial and two phase II clinical trials.[15,16,19,20,22] The phase I trial helped establish the optimum number of tumor cells and the optimum amount of virus to use in the average patient to produce the best possible immune response. Immune responses were monitored by means of a skin test that measured the extent of inflammation and hardening of the skin at vaccination sites (i.e., delayed-type hypersensitivity responses). The exact number of patients treated in this trial cannot be determined because nonidentical patient populations were described in the two published study reports.[19,20] One report lists 16 patients: 2 with stage II disease, 4 with stage III disease, and 10 with stage IV disease.[19] The second report lists 20 patients: 12 with stage II disease and 8 with stage III disease.[20] It is also not clear whether findings from individual patients were reported twice (i.e., in both trial reports). Patients with metastatic disease were allowed to enter this trial only if they had a solitary metastatic tumor.

In the trial, NDV-infected, autologous whole cell vaccines were administered to patients by intradermal injection beginning 4 weeks after surgery to remove the primary tumor or the metastatic tumor. Each patient received a total of 5 vaccinations, 4 given at 10-day intervals and a final booster given approximately 23 weeks after surgery. One of the study reports [19] states that 75% of the patients (12 of 16) showed increased immune system reactivity against uninfected, autologous tumor cells during the vaccination program. These responses were monitored by injecting uninfected, irradiated tumor cells into the skin and looking for delayed-type hypersensitivity responses. Histologic examination of several vaccination sites during the trial showed the presence of infiltrating immune system cells. These infiltrating cells were composed primarily of helper T cells; some cytotoxic T cells were also present, but B cells (i.e., antibody-producing cells) were either scarce or absent.[19]

The two phase II trials looked for evidence of therapeutic benefit in patients who had either metastatic colorectal carcinoma [15,22] or locally advanced colorectal carcinoma.[16] The trial that involved patients with metastatic disease recruited 23 individuals whose colorectal cancer had recurred in the liver following treatment of their primary tumor or whose colorectal cancer and liver metastases were diagnosed at the same time.[15,22] After surgery to remove the primary tumor and/or the metastases, all patients appeared to be free of residual cancer. NDV-infected, autologous tumor cells were then administered by intradermal injection every 2 weeks beginning 2 weeks after surgery. The total number of vaccinations given to the patients in this trial, however, is not clear. One of the two trial reports indicates that each patient received four vaccinations and a booster, which was given approximately 23 weeks after surgery.[15] The second trial report [22] indicates that each patient received five vaccinations and a booster. No additional treatment (chemotherapy or radiation therapy) was allowed during the trial.

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