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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191684
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : August 1, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 studies

Other: enzyme-linked immunosorbent assay
Correlative studies
Other Name: ELISA

Other: flow cytometry
Correlative studies

Other: immunoenzyme technique
Correlative studies
Other Name: immunoenzyme techniques

Biological: modified vaccinia virus ankara vaccine expressing p53
Given SC
Other Names:
  • MVA-p53 vaccine
  • MVAp53 vaccine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with unresectable and chemotherapy resistant primary or recurrent carcinoma of colorectal, gastric or pancreatic origin
  • There must be pathologic evidence for malignancy with a soft tissue component of tumor evident on CT scan imaging or physical examination
  • Patient must be able to give informed consent
  • There must be an anticipated survival of at least 3 months
  • Performance status of 80-100 (Karnofsky performance status)
  • WBC count >= 3,000uL
  • Platelet count >= 100,000uL
  • Prothrombin time and partial thromboplastin time of <= 1.5 times the upper limit of normal
  • Women of childbearing potential must have a negative pregnancy test; women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant during or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  • Patients with asymptomatic small volume bone disease not likely to require radiation therapy during the period of the vaccine trial will be eligible
  • Hemoglobin level > 9g/dL
  • There must be evidence of p53 over expression by immunohistochemistry with > 10% of cells within the tumor strongly positive
  • Patients with colorectal cancer will need to have failed to respond to 5-FU based therapy with oxaliplatin, irinotecan as well as epidermal growth factor receptor (EGFR) directed therapies (if appropriate); patients with gastric cancer will need to have progressed on standard first line chemotherapy or chemoradiotherapy and Herceptin based therapy (if appropriate); patients with pancreatic cancer who have failed to respond to at least 1 chemotherapy regimen

Exclusion Criteria:

  • Diagnosis which has been associated with immunodeficiency, including HIV
  • Prior radiation to more than 50% of all nodal groups
  • Concurrent use of corticosteroids
  • History of another malignancy, other than nonmelanoma skin cancer in the past 2 years
  • Recent major surgery
  • Serious intercurrent illness
  • Temperature >= 101F within 3 days prior to the initial injection
  • Pregnancy or lactation
  • Clinically evident brain metastasis
  • Autoimmune disease
  • HIV seropositivity or refusal to hear the results of the HIV test
  • Receipt of organ grafts
  • History of severe environmental allergies
  • History of severe neurological, cardiovascular, renal, hepatic, endocrine, respiratory, or bone marrow dysfunction requiring frequent re-evaluation, and management by a physician
  • Patients with a history of congestive heart failure or coronary artery disease which has not been resolved by bypass or stent
  • History of myopericarditis
  • Known family history of Li-Fraumeni syndrome
  • Allergy to egg proteins
  • Chemotherapy or radiation within the 4 weeks preceding enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191684

United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Vincent Chung, MD City of Hope Medical Center

Publications of Results:
Responsible Party: City of Hope Medical Center Identifier: NCT01191684     History of Changes
Other Study ID Numbers: 10105
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Immunologic Factors
Physiological Effects of Drugs