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

July 28, 2017 updated by: City of Hope Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: flow cytometry
Correlative studies
Biological: modified vaccinia virus ankara vaccine expressing p53
Given SC
Other Names:
  • MVA-p53 vaccine
  • MVAp53 vaccine
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Names:
  • ELISA
Other: immunoenzyme technique
Correlative studies
Other Names:
  • immunoenzyme techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assesse up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Vincent Chung, MD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (Estimate)

August 31, 2010

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10105 (DAIDS ES)
  • NCI-2010-01859

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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