Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	DUMC-2840-02-6R1 NCI-1864, NCT00027534, 1864

Objectives

1. 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.
2. Assess the CEA-specific immune response of patients treated with this regimen.
3. Assess, in a preliminary manner, the clinical response rate of patients treated with this regimen.

Entry Criteria

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

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)

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/mm³
• Absolute lymphocyte count at least 1,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 6-18 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

Herbert Lyerly, MD, Protocol chair		Ph: 919-684-5613

Registry Information
Official Title		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
Trial Start Date		2002-01-03
Registered in ClinicalTrials.gov		NCT00027534
Date Submitted to PDQ		2001-10-04
Information Last Verified		2005-09-08
NCI Grant/Contract Number		CA14236

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