Clinical Trials Directory

Trials / Completed

CompletedNCT01191684

Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer

A Phase I Study of an MVA Vaccine Targeting P53 in Cancer

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
City of Hope Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
OTHERlaboratory biomarker analysisCorrelative studies
OTHERenzyme-linked immunosorbent assayCorrelative studies
OTHERflow cytometryCorrelative studies
OTHERimmunoenzyme techniqueCorrelative studies
BIOLOGICALmodified vaccinia virus ankara vaccine expressing p53Given SC

Timeline

Start date
2011-10-01
Primary completion
2013-08-01
Completion
2013-08-01
First posted
2010-08-31
Last updated
2017-08-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01191684. Inclusion in this directory is not an endorsement.