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Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Morse, MD, Duke University Identifier:
First received: April 7, 2003
Last updated: September 4, 2014
Last verified: September 2014

RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: CEA peptide 1-6D
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Active Immunotherapy With CAP-1 (6D) and CMVpp65 Peptide-Pulsed, Autologous Dendritic Cells Produced in the Aastromreplicell Cell Production System in Patients With Stage IV CEA Expressing Malignancies

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Safety [ Time Frame: 12 months ]
    The safety and feasibility of administering one cycle of CAP-1(6D) and CMV pp65 peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

Secondary Outcome Measures:
  • Immune response [ Time Frame: 12 weeks ]
    The ability of the epitope pulsed DC to induce CAP-1(6D) and CMV pp65-specific T cells

Enrollment: 4
Study Start Date: September 2003
Study Completion Date: September 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CEA peptide 1-6D
CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Biological: CEA peptide 1-6D
CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Other Name: carcinoembryonic antigen peptide 1-6D

Detailed Description:


  • Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D (CAP 1-6D)- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies.
  • Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients.
  • Determine the antitumor effect of this regimen, in terms of progression-free survival, of these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells (DC) are generated and pulsed with carcinoembryonic antigen peptide 1-6D (CAP 1-6D) and CMV pp65 peptide. Patients are assigned to 1 of 2 vaccination cohorts.

  • Cohort I: Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations.
  • Cohort II: Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations.

For both cohorts, a safe dose of the vaccine is defined as the dose at which no more than 1 of 6 patients experiences unacceptable toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 12 patients (6 per cohort) will be accrued for this study within 24 months.


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


  • Histologically confirmed malignancy that is refractory to standard therapy known to have a survival benefit

    • Stage IV disease
  • Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following:

    • Immunohistochemistry with at least 50% of the tumor with at least moderate intensity of staining
    • Peripheral blood CEA greater than 2.5 mg/dL
    • Tumor known to be universally CEA positive (i.e., colon or rectal cancer)
  • HLA-A201 positive
  • Measurable disease*

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Histologic or cytologic confirmation is not required for measurable disease restricted to a solitary lesion
  • Received at least 1 prior standard chemotherapy regimen known to have a survival benefit
  • Previously resected brain metastases allowed provided CT scan or MRI was performed within the past month and shows no metastasis



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 6 months


  • WBC at least 3,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors [e.g., epoetin alfa] allowed)
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease)
  • SGOT/SGPT less than 1.5 times upper limit of normal
  • No hepatic disease that would preclude study participation
  • No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and hepatitis C serology


  • Creatinine less than 2.5 mg/dL
  • No urinary tract infection


  • No New York Heart Association class III or IV heart disease


  • No history of autoimmune disease, including any of the following:

    • Inflammatory bowel disease
    • Systemic lupus erythematosus
    • Ankylosing spondylitis
    • Scleroderma
    • Multiple sclerosis
  • No active acute or chronic infection
  • HIV negative


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious chronic or acute illness that would preclude study participation
  • No medical or psychological impediment that would preclude study compliance
  • No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
  • No allergy to study vaccine components


Biologic therapy

  • At least 4 weeks since prior immunotherapy
  • No other concurrent immunotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • At least 6 weeks since prior steroid therapy (except steroids administered as premedication for chemotherapy or contrast-enhanced studies)
  • Concurrent hormonal therapy allowed for patients with breast cancer
  • No concurrent steroid therapy


  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • Not specified


  • Recovered from prior therapy
  • At least 4 weeks since prior investigational therapy
  • At least 4 weeks since other prior therapy
  • Any number of prior therapies are allowed
  • Concurrent bisphosphonates allowed for bone metastases
  • No concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine)
  • No other concurrent experimental therapies
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00057915

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Study Chair: Herbert K. Lyerly, MD Duke Cancer Institute
  More Information

Responsible Party: Michael Morse, MD, Principal Investigator, Duke University Identifier: NCT00057915     History of Changes
Other Study ID Numbers: 4180
5910 ( Other Grant/Funding Number: NCI )
4180 ( Other Identifier: Duke IRB )
Study First Received: April 7, 2003
Last Updated: September 4, 2014

Keywords provided by Duke University:
unspecified adult solid tumor, protocol specific processed this record on May 24, 2017