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. Author manuscript; available in PMC: 2009 Dec 1.
Published in final edited form as: Expert Opin Biol Ther. 2008 Dec;8(12):1947–1953. doi: 10.1517/14712590802567298

TABLE.

Clinical Trials with MVA-5T4

Clinical Trials.gov Identifier Trial Phase Trial Format Disease MVA-5T4 Doses Pfu/dose Concomitant Systemic Treatment Evaluable Patients Study Status Reference
Single Agent Studies
None I/II Open-label CRC 5 Dose escalation to 5 ×10^8 None 17 Completed [22]
NCT00259844 II Open-label CRC 6 Not stated None (surgery) 16 Completed [23]
Combination Studies
None II Open-label CRC 6 5 × 10^8 5-FU/leukovorin/oxaliplatin 11 Completed [24]
None II Open-label CRC 6 5 × 10^8 5-FU/leukovorin/irinotecan 12 Completed [25]
NCT00445523 II Single center open-label RCC 10 Not stated None vs IFN-α Not stated Completed [26]
None I/II Open-label RCC Not Stated Not stated IFN-α 11 Closed [27]
NCT00325507 II Single center open-label RCC 8 Not stated IL-2 (low dose) 25 Completed [26, 28]
NCT00083941 II Single center open-label RCC 8 Not stated IL-2 (high dose) 22 Completed [29]
NCT00397345 III Multicenter randomized double-blind placebo- controlled RCC 13 1 × 10^9 IFN-αIL-2 Sunitinib 733 Closed [30]
NCT00448409 II Single center open-label HRPC 11 5 × 10^8 None vs GM-CSF 24 Completed [32]
NCT00521274 II Single center open-label HRPC 12 Not stated Docetaxel 60 (planned) Stopped by Sponsor [33]

Notes: abbreviations: pfu = plaque forming unit; CRC= colorectal cancer; RCC = renal cell carcinoma; HRPC = hormone-refractory prostate cancer; 5-FU = 5-fluoruracil; IFN-α = interferon-alfa; IL-2 = interleukin-2; GM-CSF = granulocyte-macrophage colony stimulating factor.