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