Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Morse, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00027534
First received: December 7, 2001
Last updated: February 21, 2013
Last verified: February 2013

December 7, 2001
February 21, 2013
January 2002
October 2007   (final data collection date for primary outcome measure)
Safety [ Time Frame: 12-36 weeks ] [ Designated as safety issue: Yes ]
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.
Not Provided
Complete list of historical versions of study NCT00027534 on ClinicalTrials.gov Archive Site
Immune response [ Time Frame: 12-36 weeks ] [ Designated as safety issue: No ]
The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated
Not Provided
Not Provided
Not Provided
 
Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
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

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.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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)
dendritic cells loaded with TRICOM-CEA(6D)
Other Names:
  • TRICOM-CEA(6D)
  • recombinant fowlpox-CEA(6D)/TRICOM vaccine
Experimental: TRICOM-CEA(6D)
Subjects receiving TRICOM-CEA(6D)
Intervention: Biological: TRICOM-CEA(6D)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2007
October 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over Sex
  • Male or female Menopausal status
  • Not specified Performance status
  • Karnofsky 70-100% Life expectancy
  • More than 6 months

Hematopoietic

  • 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

Renal

  • Creatinine less than 2.5 mg/dL
  • No active acute or chronic urinary tract infection

Cardiovascular

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior biologic therapy and recovered
  • No other concurrent immunotherapy

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

  • Not specified

Other

  • At least 4 weeks since any other prior therapy (including experimental therapy) and recovered
  • No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00027534
CDR0000069041, 2840, 1R21CA094523, 2840
No
Michael Morse, MD, Duke University Medical Center
Michael Morse, MD
National Cancer Institute (NCI)
Study Chair: Herbert K. Lyerly, MD Duke Cancer Institute
Duke University
February 2013

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