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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01191684
First received: August 27, 2010
Last updated: August 21, 2013
Last verified: August 2013

August 27, 2010
August 21, 2013
October 2011
August 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Safety data for each administered dose will be summarized using descriptive numbers and 95% confidence intervals from the exact binomial distributions
Safety as assessed by CTCAE V.4 toxicity scale [ Time Frame: 1 week after the third dose of vaccine ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01191684 on ClinicalTrials.gov Archive Site
Immunogenicity [ Time Frame: Assesse up to 12 months ] [ Designated as safety issue: No ]
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.
Immunogenicity as assessed by using an ELISA assay for humoral response, lymphoproliferation for CD4+ T cell response and intracytoplasmic cytokine assays, and IFN-gamma and IL-4 by ELISPOT assays for the assessment of cellular immune response [ Time Frame: 1 year after first vaccine administration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    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
Experimental: Treatment (vaccine therapy)
Patients receive MVAp53 subcutaneously on days 0, 21, and 42 in the absence of unacceptable toxicity.
Interventions:
  • Other: laboratory biomarker analysis
  • Other: enzyme-linked immunosorbent assay
  • Other: flow cytometry
  • Other: immunoenzyme technique
  • Biological: modified vaccinia virus ankara vaccine expressing p53
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01191684
10105, NCI-2010-01859
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Vincent Chung, MD City of Hope Medical Center
City of Hope Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP