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Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
This study has been completed.
Study NCT00057915   Information provided by National Cancer Institute (NCI)
First Received: April 7, 2003   Last Updated: February 6, 2009   History of Changes

April 7, 2003
February 6, 2009
September 2003
 
 
 
Complete list of historical versions of study NCT00057915 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
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

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.

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.

Phase I
Interventional
Treatment, Open Label
Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: CMV pp65 peptide
  • Biological: carcinoembryonic antigen peptide 1-6D
  • Biological: therapeutic autologous dendritic cells
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
12
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057915
 
CDR0000285629, DUMC-4180-03-10R1, NCI-5910
Duke University
National Cancer Institute (NCI)
Study Chair: Herbert K. Lyerly, MD Duke University
National Cancer Institute (NCI)
September 2006

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