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Vaccine Therapy in Treating Patients With Advanced or Metastatic 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: NCT00027534
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 8, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Morse, MD, Duke University

Tracking Information
First Submitted Date  ICMJE December 7, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date September 8, 2014
Study Start Date  ICMJE January 2002
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Safety [ Time Frame: 12-36 weeks ]
The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00027534 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Immune response [ Time Frame: 12-36 weeks ]
The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
Official Title  ICMJE A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA
Brief Summary

RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.

Detailed Description


  • Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA.
  • Assess the CEA-specific immune response of patients treated with this regimen.
  • Assess, in a preliminary manner, the clinical response rate of patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the absence of unacceptable toxicity.

Cohorts of 6 patients receive an escalating number of immunizations until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Colorectal Cancer
  • Gallbladder Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Liver Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Testicular Germ Cell Tumor
Intervention  ICMJE Biological: TRICOM-CEA(6D)
dendritic cells loaded with TRICOM-CEA(6D)
Other Name: recombinant fowlpox-CEA(6D)/TRICOM vaccine
Study Arms  ICMJE Experimental: TRICOM-CEA(6D)
Subjects receiving TRICOM-CEA(6D)
Intervention: Biological: TRICOM-CEA(6D)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2013)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • Histologically confirmed advanced or metastatic malignancy expressing CEA

    • Metastatic disease meeting one of the following criteria:

      • Measurable or nonmeasurable
      • History of metastases but no current evidence of disease, meeting one of the following criteria:

        • Unresectable peritoneal or lymph node metastases that cannot be detected by imaging
        • Treated or resected metastatic disease considered at high risk of recurrence (predicted 5-year disease-free survival of less than 50%)

          • Must have completed treatment that rendered no evidence of disease within the past year
  • CEA-expressing malignancy is defined by any of the following:

    • Immunohistochemical staining (at least 50% of the tumor has at least a moderate intensity of staining)
    • CEA level in peripheral blood greater than 2.5 µg/L
    • Tumor known to be universally CEA positive (e.g., colon and rectal cancer)
  • Received prior therapy with possible survival benefit or refused such therapy
  • Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI of the brain within 1 month of enrollment
  • Hormone receptor status:

    • Not specified



  • 18 and over Sex
  • Male or female Menopausal status
  • Not specified Performance status
  • Karnofsky 70-100% Life expectancy
  • More than 6 months


  • WBC at least 3,000/mm^3
  • Absolute lymphocyte count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic
  • Bilirubin less than 2.0 mg/dL
  • SGOT/SGPT less than 1.5 times upper limit of normal
  • No active acute or chronic viral hepatitis
  • Hepatitis B surface antigen negative
  • Hepatitis C negative
  • No other hepatic disease that would preclude study entry


  • Creatinine less than 2.5 mg/dL
  • No active acute or chronic urinary tract infection


  • No New York Heart Association class III or IV heart disease Immunologic
  • HIV negative
  • No history of autoimmune disease, including, but not limited to, the following:

    • Inflammatory bowel disease
    • Systemic lupus erythematosus
    • Rheumatoid arthritis
    • Ankylosing spondylitis
    • Scleroderma
    • Multiple sclerosis
  • No allergy to eggs or any component of study vaccine Other
  • No active acute or chronic infection
  • No concurrent serious acute or chronic illness that would preclude study entry
  • No other medical or psychological impediment that would preclude study entry
  • No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • At least 4 weeks since prior biologic therapy and recovered
  • No other concurrent immunotherapy


  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • At least 4 weeks since prior hormonal therapy and recovered
  • At least 6 weeks since prior steroids except steroids used as premedication for chemotherapy or for contrast-enhanced studies
  • No concurrent steroids


  • Prior palliative radiotherapy (including systemic radiolabeled compounds) for unstable or painful bone metastases in weight-bearing bones may be allowed
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • Not specified


  • At least 4 weeks since any other prior therapy (including experimental therapy) and recovered
  • No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00027534
Other Study ID Numbers  ICMJE 2840
1R21CA094523 ( U.S. NIH Grant/Contract )
2840 ( Other Identifier: Duke IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Morse, MD, Duke University
Study Sponsor  ICMJE Michael Morse, MD
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Herbert K. Lyerly, MD Duke Cancer Institute
PRS Account Duke University
Verification Date September 2014

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