Review Article
DNA Vaccines: Developing New Strategies against Cancer
Table 4
Phases I/II-II clinical trials: key summary.
| Tumor | Study ID | Patients no. | Objectives | Status | Response | Side effects |
| Lymphoma | | | Determine the safety, | | Absence of toxicity | | UK-007 | 25 | dose, immunogenicity | Completed | Cellular and/or | | | | | | humoral responses | |
| Prostate cancer | | | Determine the feasibility | | | | | | and safety | | | | | | Determine the safety and | Open | | | NCT00859729 | 18 | functionality of DNA | recruiting | | | | | vaccine delivery system | | | | | | Determine the | | Absence of toxicity | Brief and | | | feasibility and safety | Open | CD8+ T-cell | acceptable | UK-112 | 20 | Determine the | | reactivity against the | pain at the | | | immunological responses | | target peptide | injection site | | | | | PAP-specific IFN | | | | | | gamma-secreting | | NCT00582140 | 22 | Determine the safety | Completed | CD8+ T-cells | | | | | (Aug 2009) | PAP-specific | | | | | | CD4+ and/or CD8+ | | | | | | T-cell proliferation | | Bulgarian | | Characterize the humoral | | Specific humoral | | Drug | 52 | immune response | Completed | immune response | | Agency Register | | against PSMA | | against PSMA | |
| Melanoma | | | Determine the safety | | Antigen-specific | Grade I/II toxicity | | | and tolerability | | Immunity | NCT00033228 | 6–18 | Determine the | Completed | No regression of | | | immunological and | (July 2009) | established disease | | | clinical responses | | | | | Determine the safety | Open | Immunological | Grade I toxicity | | | and tolerability | Not | efficacy | NCT00085137 | 3–27 | Determine any | Recruiting | in terms of | | | antitumor response | | T-cell response |
| | | | Determine the feasibility | | | | | | | and toxicity | | Absence of | | | | | Determine the effect | | toxicity | | | | | Determine changes | | In the highest-dose | | | | | in lesion size and | Open | cohort the number | | | | | HPV viral load | Not | of patients with | | Cervical cancer | NCT00121173 | 150 | Determine the immune | Recruiting | complete histologic | Transient | | | | responses | | regression is | injection-site | | | | Correlate measures of | | higher than the | discomfort | | | | immune response with | | unvaccinated cohort, | | | | | clinical response | | but not significant. | |
| | | | Determine the dose- | | | | | | | limiting toxicity and | | | | | | | maximum tolerated dose | | | | Liver cancer | NCT00093548 | 3–25 | Determine the optimal | Completed | Absence of | | | | | biological dose | (Feb 2009) | toxicity | | | | | Determine disease-free | | | | | | | survival of patients treated | | | |
| | | | Determine and | | | | | | | characterize | | | | Breast cancer | NCT00363012 | 56 | the immunologic | Open | Absence of | | | | | memory | recruiting | toxicity | | | | | to the HER2-ICD | | | |
|
|