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. Author manuscript; available in PMC: 2007 Nov 5.
Published in final edited form as: Vaccine. 2007 Jun 4;25(Suppl 2):B89–B96. doi: 10.1016/j.vaccine.2007.04.091

Table 1.

Results of clinical trials utilizing therapeutic vaccinations in combination with conventional therapies.

Patient Population N Treatment Regimen Results Ref
Localized prostate
cancer		 30 External beam radiation alone or
in combination with poxviral-
based PSA vaccine		 17 pts completed therapy, 13 had ≥3-fold
increase in T cells specific for PSA.
Additional responses to other TAAs seen.
These results were not seen in the 11 pts
treated with radiation alone.		 [11]
Metastatic AIPC 28 Poxviral-based PSA vaccine
alone or in combination with
docetaxel (with dexamethasone)		 Both arms had a median 3.33-fold increase
in PSA-specific T cells after 3 months of
treatment. These results indicate the
immune response was not mitigated by
chemotherapy. Responses to other TAAs
were seen. Patients treated with vaccine in
combination with docetaxel had a longer OS
than expected based on historical controls.		 [37]
Advanced-stage
cancer		 17 Plasmid vaccine against
cytochrome P4501B1 in
combination with salvage
regimen		 5/6 pts who generated an immune response
also had a sustained response to the salvage
regimen. 2/5 responders sustained a
complete response at 17- and 20-month
follow-up, respectively.		 [39]
Small cell lung
cancer		 29 Dendritic cells transduced with
p53 vaccine via adenovirus		 61.9% of pts treated with chemotherapy
after vaccine had an objective response.
57.1% of pts generated a p53-specific T-cell
response. Clinical response and OS were
higher in pts who developed an immune
response.		 [40]
Nonmetastatic AIPC 42 Nilutamide vs. poxviral-based
PSA vaccine, with cross-over to
both at biochemical progression		 Pts (n=12) who started with vaccine and
crossed over to nilutamide at progression
had a TTF of 25.9 months and 5-year OS of
75%. Pts (n=8) who started on nilutamide
and crossed over to vaccine at progression
had a TTF of 15.9 months and 5-year OS
of 43%.		 [49]
Metastatic AIPC 10 Whole tumor-cell vaccine in
combination with
anti-CTLA-4 antibody		 5/6 pts treated with the higher dose levels
had >50% decline in PSA. Some pts with
PSA declines had decreases in bone and soft
tissue lesions.		 [63]
Symptomatic
metastatic AIPC		 600 Whole tumor-cell vaccine with
docetaxel chemotherapy vs.
chemotherapy alone		 Trial accruing. [66]

AIPC = androgen-independent prostate cancer; pts = patients; TAA = tumor-associated antigen; OS = overall survival; TTF = time to treatment failure