Clinical trialPhase 1Completed
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
A Phase I Study of an MVA Vaccine Targeting P53 in Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 22 December 2011
- Expected end
- 19 August 2013
- Enrollment
- 12 participants
- Sites
- 1
- Primary outcomes
- Safety and tolerance of modified vaccinia virus ankara vaccine expressing p53 assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4 toxicity scale
- Sponsor
- Other
- Results posted
- No
- Last update
- 19 October 2026
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Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Papers 1
- Registry-listed results paperp53MVA therapy in patients with refractory gastrointestinal malignancies elevates p53-specific CD8+ T-cell responses. DOI 10.1158/1078-0432.ccr-13-3361↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.