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Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Colorectal Cancer; Gallbladder Cancer; Gastric Cancer; Head and Neck Cancer; Liver Cancer; Ovarian Cancer; Pancreatic Cancer; Testicular Germ Cell Tumor

Intervention: TRICOM-CEA(6D) (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Michael Morse, MD

Official(s) and/or principal investigator(s):
Herbert K. Lyerly, MD, Study Chair, Affiliation: Duke Cancer Institute


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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety

Secondary outcome: Immune response

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- 18 and over Sex

- Male or female Menopausal status

- Not specified Performance status

- Karnofsky 70-100% Life expectancy

- More than 6 months


- 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


- Creatinine less than 2. 5 mg/dL

- No active acute or chronic urinary tract infection


- 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


- At least 4 weeks since prior biologic therapy and recovered

- No other concurrent immunotherapy


- 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


- 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


- Not specified


- At least 4 weeks since any other prior therapy (including experimental therapy) and


- No concurrent immunosuppressives (e. g., azathioprine or cyclosporine)

Locations and Contacts

Duke Comprehensive Cancer Center, Durham, North Carolina 27705, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2002
Last updated: September 4, 2014

Page last updated: August 23, 2015

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