Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Morse, MD, Duke University
ClinicalTrials.gov Identifier:
NCT00057915
First received: April 7, 2003
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057915

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

Additional Information:
No publications provided

Responsible Party: Michael Morse, MD, Principal Investigator, Duke University
ClinicalTrials.gov Identifier: NCT00057915     History of Changes
Other Study ID Numbers: 4180, 5910, 4180
Study First Received: April 7, 2003
Last Updated: February 21, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Duke University:
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 14, 2014