Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Phase I Study of an MVA Vaccine Targeting P53 in Cancer
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective
immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in
treating patients with colorectal, stomach, or pancreatic cancer.
PRIMARY OBJECTIVES:I. To establish whether 2 vaccine dose levels of modified vaccinia virus
ankara vaccine expressing p53 (MVAp53) vaccines are safe and well tolerated in patients with
p53 over-expressing solid tumor malignancy.
SECONDARY OBJECTIVES:I. To provide preliminary evidence of enhanced cellular and humoral
immunity to p53.
OUTLINE:This is a phase I, dose-escalation trial of modified vaccinia virus ankara vaccine
expressing p53 (MVAp53).Patients receive MVAp53 subcutaneously (SC) on days 0, 21, and 42 in
the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up annually for 5 years.
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