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CompletedNCT00057915Updated Sep 8, 2014

Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer

A Phase 1 interventional study of CEA peptide 1-6D in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-08.

Sponsored by Duke University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 6 months

Hematopoietic

  • 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

Hepatic

  • 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

Renal

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

Cardiovascular

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

Immunologic

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • Not specified

Other

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalCEA peptide 1-6D

    CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

    Also known as: carcinoembryonic antigen peptide 1-6D

06

What researchers measure

Primary outcomes

  1. Safety

    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

    Time frame: 12 months

Secondary outcomes

  1. Immune response

    The ability of the epitope pulsed DC to induce CAP-1(6D) and CMV pp65-specific T cells

    Time frame: 12 weeks

07

Study locations

1 site
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00057915
Lead sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
Responsible party
Michael Morse, MD (Principal Investigator, Duke University) — Principal investigator
First posted
Apr 9, 2003
Start date
Sep 2003
Primary completion
Aug 2006
Completion
Sep 2006
Last update
Sep 8, 2014

Study contacts

Herbert K. Lyerly, MD
study chair · Duke Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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