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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Gallbladder Cancer Gastric Cancer Head and Neck Cancer Liver Cancer Ovarian Cancer Pancreatic Cancer Testicular Germ Cell Tumor Biological: TRICOM-CEA(6D) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2002
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Arm Intervention/treatment
Experimental: TRICOM-CEA(6D)
Subjects receiving TRICOM-CEA(6D)
Biological: TRICOM-CEA(6D)
dendritic cells loaded with TRICOM-CEA(6D)
Other Name: recombinant fowlpox-CEA(6D)/TRICOM vaccine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Immune response [ Time Frame: 12-36 weeks ]
    The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • 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)

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): NCT00027534

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Michael Morse, MD
National Cancer Institute (NCI)
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Study Chair: Herbert K. Lyerly, MD Duke Cancer Institute
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Responsible Party: Michael Morse, MD, Principal Investigator, Duke University Identifier: NCT00027534    
Other Study ID Numbers: 2840
1R21CA094523 ( U.S. NIH Grant/Contract )
2840 ( Other Identifier: Duke IRB )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Keywords provided by Michael Morse, MD, Duke University:
recurrent colon cancer
stage III colon cancer
stage IV colon cancer
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer
recurrent pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
recurrent gallbladder cancer
unresectable gallbladder cancer
thyroid gland medullary carcinoma
recurrent salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
Paget disease of the breast with intraductal carcinoma
Paget disease of the breast with invasive ductal carcinoma
adult primary hepatocellular carcinoma
diffuse adenocarcinoma of the stomach
intestinal adenocarcinoma of the stomach
Additional relevant MeSH terms:
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Breast Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Gallbladder Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Liver Diseases
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents