Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic 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.
|Recurrent Colon Cancer Recurrent Gastric Cancer Recurrent Pancreatic Cancer Recurrent Rectal Cancer Stage III Colon Cancer Stage III Gastric Cancer Stage III Pancreatic Cancer Stage III Rectal Cancer Stage IV Colon Cancer Stage IV Gastric Cancer Stage IV Pancreatic Cancer Stage IV Rectal Cancer||Other: laboratory biomarker analysis Other: enzyme-linked immunosorbent assay Other: flow cytometry Other: immunoenzyme technique Biological: modified vaccinia virus ankara vaccine expressing p53||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of an MVA Vaccine Targeting P53 in Cancer|
- 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 [ Time Frame: Assessed up to 12 months ]Safety data for each administered dose will be summarized using descriptive numbers and 95% confidence intervals from the exact binomial distributions
- Immunogenicity [ Time Frame: Assesse up to 12 months ]Assessed using enzyme-linked immunosorbent assay (ELISA) for humoral response, lymphoproliferation for cluster of differentiation (CD)4+ T cell response, and intracytoplasmic cytokine assays, and interferon (IFN)-gamma and interleukin (IL)-4 by enzyme-linked immunosorbent spot (ELISPOT) for the assessment of cellular immune response. For each assay, the pre-vaccine values will be compared to the highest post-vaccine values. Immunogenicity changes and the maximum change will be quantified by mean, standard deviation, median, and range and tested by paired t-test at the 0.05 significance level.
|Study Start Date:||October 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (vaccine therapy)
Patients receive MVAp53 subcutaneously on days 0, 21, and 42 in the absence of unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studiesOther: enzyme-linked immunosorbent assay
Other Name: ELISAOther: flow cytometry
Correlative studiesOther: immunoenzyme technique
Other Name: immunoenzyme techniquesBiological: modified vaccinia virus ankara vaccine expressing p53
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191684
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Vincent Chung, MD||City of Hope Medical Center|